    [Senate Hearing 110-790]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 110-790

                      DEVELOPING A COMPREHENSIVE RESPONSE
                                 TO FOOD SAFETY

    =======================================================================

                                    HEARING

                                     OF THE

                        COMMITTEE ON HEALTH, EDUCATION,
                              LABOR, AND PENSIONS

                              UNITED STATES SENATE

                           ONE HUNDRED TENTH CONGRESS

                                 FIRST SESSION

                                       ON

     EXAMINING DEVELOPING A COMPREHENSIVE RESPONSE TO FOOD SAFETY PROBLEMS

                                   __________

                                DECEMBER 4, 2007

                                   __________

     Printed for the use of the Committee on Health, Education, Labor, and
                                    Pensions

      Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                                     senate

                                   ----------
                             U.S. GOVERNMENT PRINTING OFFICE

    39-554 PDF                       WASHINGTON : 2009

    For sale by the Superintendent of Documents, U.S. Government Printing
    Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800;
    DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC,
    Washington, DC 20402-0001

              COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                   EDWARD M. KENNEDY, Massachusetts, Chairman
    CHRISTOPHER J. DODD, Connecticut     MICHAEL B. ENZI, Wyoming,
    TOM HARKIN, Iowa                     JUDD GREGG, New Hampshire
    BARBARA A. MIKULSKI, Maryland        LAMAR ALEXANDER, Tennessee
    JEFF BINGAMAN, New Mexico            RICHARD BURR, North Carolina
    PATTY MURRAY, Washington             JOHNNY ISAKSON, Georgia
    JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
    HILLARY RODHAM CLINTON, New York     ORRIN G. HATCH, Utah
    BARACK OBAMA, Illinois               PAT ROBERTS, Kansas
    BERNARD SANDERS (I), Vermont         WAYNE ALLARD, Colorado
    SHERROD BROWN, Ohio                  TOM COBURN, M.D., Oklahoma
               J. Michael Myers, Staff Director and Chief Counsel
               Katherine Brunett McGuire, Minority Staff Director

                                      (ii)

                                C O N T E N T S

                                  ----------

                                   STATEMENTS

                           TUESDAY, DECEMBER 4, 2007

                                                                       Page
    Kennedy, Hon. Edward M., Chairman, Committee on Health,
      Education, Labor, and Pensions, opening statement..............     1
    Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming,
      opening statement..............................................     4
    Harkin, Hon. Tom, a U.S. Senator from the State of Iowa,
      statement......................................................     6
        Prepared statement...........................................     7
    Burr, Hon. Richard, a U.S. Senator from the State of North
      Carolina, statement............................................     9
    Allard, Hon. Wayne, a U.S. Senator from the State of Colorado,
      statement......................................................     9
    Leavitt, Michael, Secretary, Department of Health and Human
      Services, Washington, DC.; accompanied by Dr. David Acheson,
      Deputy Commissioner, Food Safety...............................    10
        Prepared statement...........................................    14
    Murkowski, Hon. Lisa, a U.S. Senator from the State of Alaska,
      statement......................................................    22
    Murray, Hon. Patty, a U.S. Senator from the State of Washington,
      statement......................................................    24
    Roberts, Hon. Pat, a U.S. Senator from the State of Kansas,
      statement......................................................    26
    Taylor, Michael R., Research Professor of Health Policy, The
      George Washington University, Washington, DC...................    33
        Prepared statement...........................................    36
    Corby, J. Joseph, Director, New York Department of Agriculture &
      Markets, Albany, NY............................................    42
        Prepared statement...........................................    44
    Dooley, Cal, President & Chief Executive Officer, Grocery
      Manufacturers Association, Washington, DC......................    53
        Prepared statement...........................................    54
    DeWaal, Caroline Smith, Food Safety Director, Center for Science
      in the Public Interest, Washington, DC.; accompanied by David
      Plunkett, Senior Staff Attorney................................    56
        Prepared statement...........................................    57
    Young, Paul, Ph.D., Senior Marketing Manager, Waters Corporation,
      Newtownards, N. Ireland........................................    62
        Prepared statement...........................................    63

                                     (iii)

                              ADDITIONAL MATERIAL

    Statements, articles, publications, letters, etc.:
        American Frozen Food Institute (AFFI)........................    31
        Safe Food International--World Health Organization...........    75
        Response by Michael Leavitt to questions of:
            Senator Kennedy..........................................    81
            Senator Harkin...........................................    83
            Senator Mikulski.........................................    85
            Senator Bingaman.........................................    86
            Senator Brown............................................    87
            Senator Enzi.............................................    88
            Senator Burr.............................................    90
            Senator Hatch............................................    94
            Senator Allard...........................................    95
        Response by Michael R. Taylor to questions of:
            Senator Kennedy..........................................    96
            Senator Harkin...........................................   100
            Senator Enzi.............................................   100
            Senator Burr.............................................   102
            Senator Allard...........................................   103
        Response by J. Joseph Corby to questions of:
            Senator Kennedy..........................................   103
            Senator Enzi.............................................   104
            Senator Burr.............................................   105
            Senator Allard...........................................   106
        Response by Cal Dooley to questions of:
            Senator Kennedy..........................................   106
            Senator Enzi.............................................   108
            Senator Burr.............................................   108
            Senator Allard...........................................   109
        Response by Caroline Smith DeWaal to questions of:
            Senator Kennedy..........................................   109
            Senator Harkin...........................................   113
            Senator Enzi.............................................   114
            Senator Allard...........................................   115
        Response by Paul Young to questions of:
            Senator Kennedy..........................................   117
            Senator Enzi.............................................   118
            Senator Allard...........................................   119

               DEVELOPING A COMPREHENSIVE RESPONSE TO FOOD SAFETY

                                  ----------

                           TUESDAY, DECEMBER 4, 2007

                                           U.S. Senate,
           Committee on Health, Education, Labor, and Pensions,
                                                        Washington, DC.
        The committee met, pursuant to notice, at 10:29 a.m., in
    Room SD-430, Dirksen Senate Office Building, Hon. Edward M.
    Kennedy, chairman of the committee, presiding.
        Present: Senator Kennedy, Harkin, Murray, Enzi, Burr,
    Murkowski, Roberts, and Allard.

                      Opening Statement of Senator Kennedy

        The Chairman. We'll come to order.
        The most basic duty of any government is to protect the
    safety of the people it serves. A recent report to the FDA
    Science Advisory Board raises troubling questions about the
    Administration's ability to meet this basic responsibility with
    regard to food safety and many other areas where American
    families count on FDA to protect their health. Instead of
    improving matters the White House is poised to make them worse
    by threatening to veto the very bill that funds the FDA.
        The report's conclusions cannot be more stark or more
    shocking. FDA does not have the capacity to ensure the safety
    of the food for the Nation. FDA's ability to provide its basic
    food system inspection, enforcement, and rulemaking function is
    seriously eroded, as is its ability to respond to the outbreaks
    in a timely manner and to develop the new regulatory approaches
    needed to prevent future problems.
        Every time American families go to the grocery store, they
    worry about the safety of the food that they buy. Every time
    parents buy toys for their children, they worry if the paint is
    contaminated or the materials are defective. They ought to be
    able to count on the FDA and other health agencies to stand
    guard for them to use the latest and best science to protect
    them and to stop at nothing to detect dangerous products.
        But the Advisory Committee report reveals that FDA's
    promise to protect America's families is too often an empty one
    because of the starvation budgets and absent leadership that
    the FDA has endured in recent years. The plain truth is the FDA
    doesn't have the money it needs to do the job it has to do. If
    the problems revealed by the report were confined to food
    safety they'd be disturbing enough, but the study shows that
    the effectiveness of the entire agency has been eviscerated by
    neglect.
        The major findings of the report read like an indictment.
    Finding No. 1, the FDA cannot fulfill its mission, the FDA
    cannot fulfill its mission, because its scientific base has
    eroded and its scientific organizational structure is weak. No.
    2, the FDA cannot fulfill its mission because its scientific
    workforce does not have sufficient capacity and capability. And
    finding No. 3, the FDA cannot fulfill its mission because its
    information technology infrastructure is inadequate.
        I'm pleased that we are joined by Secretary Leavitt today.
    I welcome him to our committee. And I hope he'll take this
    opportunity to explain to the American people how FDA has been
    allowed to reach this sorry state.
        I also look forward to a thorough examination of how to
    improve food safety. Even a brief review of recent food safety
    concerns must ring alarm bells in every community. Salmonella
    was found in domestic peanut butter. Botulism was found in
    chili. An adulterant from China in pet foods led to illness and
    deaths in cats and dogs.
        An E. coli outbreak in spinach from California last summer
    killed three and sickened more than 200 others. I don't have to
    look far to see the threat from E. coli. On Cape Cod last month
    we were told to boil our drinking water because it was
    contaminated with these dangerous bacteria.
        The Administration's food safety plan offers
    recommendations on improving food safety. And I look forward to
    hearing Secretary Leavitt's discussion of this proposal.
    However many experts believe we ought to do far more and I look
    forward to the views of our distinguished panel on the matter.
        Both the European Union and the Japanese have more robust
    food safety programs than we do. And we can learn from them.
    Most significantly they have much stronger programs to police
    imported food, combining inspections in the country of origin
    and testing of imported foods. And we should be able to do at
    least as well.
        We need to give the FDA the tools it needs to identify food
    safety problems more quickly and respond more effectively. Most
    importantly we need to focus on preventing outbreaks in food. I
    know the Secretary's proposal is going to talk about the issues
    of prevention. And we'll have a discussion on these matters.
        Each part of the food industry must have an effective plan
    in place to prevent hazards in the food it makes and markets.
    Preventive controls aren't new and they work. The FDA has had
    regulations in effect since 1973 to require safety processing
    for many canned foods. Because of these regulations, there are
    now virtually no problems with botulism in these foods.
        FDA issued regulations in 2001 to require safety processing
    for juices after E. coli in apple juice killed or injured
    children. Most manufacturers now pasteurize their juice, which
    eliminates this contamination. And despite the effectiveness of
    these regulations the Administration plan proposes to expand
    this authority only with major limits. Under the proposal FDA
    will be able to impose preventive controls only for foods that
    have repeatedly been associated with serious adverse health
    consequences or death.
        Essentially this provision is a requirement that people be
    injured or even killed before FDA can act. Such a requirement
    undermines the basic goal of preventing illness. Every
    manufacturer should be required to implement effective
    preventive controls and we must give the FDA the authority to
    enforce the requirement before people are injured, not make
    them wait until the damage is done.
        The HELP committee worked together this year to reauthorize
    user fee programs that provide significant resources for FDA.
    We need to be similarly creative to meet the agency's other
    pressing needs. It is a privilege to work with Senator Enzi on
    this hearing and I look forward to working with him and our
    committee colleagues to develop a response to food safety.
        Mr. Secretary, we welcome you. We have the extraordinary
    circumstance where the head of the FDA asked the Science
    Advisory Committee to give guidance with regards to what the
    agency needs in terms of expertise and science advice. And they
    made a series of recommendations on it and what can be done in
    terms of safety.
        So we want to give credit to the agency in trying to look
    at itself about how it ought to improve itself. And for going
    outside and asking the distinguished panel, who, I think, have
    demonstrated with their recommendations a willingness to give
    us the unvarnished situation, which I think the American people
    are entitled to.
        You have gone and traveled the world to look at food safety
    and you've been kind enough to come and brief me. I'm sure you
    have briefed others on the committee about what you have been
    attempting to do. But you've landed in the hot spot right now.
        Because, food safety must be of central concern to American
    families and this advisory panel report raises issues of what
    is needed by way of resources to give protection to the
    American people through food safety. And we are confronted with
    the President stating that he's going to veto the FDA funding
    that would help address these very needs. All of these have
    come together right now in terms of the public policy issue.
        We have a clear, unbiased series of recommendations that
    are about as fierce an indictment of a governmental agency as
    I've seen in 45 years of being in the U.S. Senate, certainly
    with regards to the HELP panel. I'm someone who's been deeply
    committed to the FDA, as others have been on this panel. We've
    worked very closely with Senator Enzi and Senator Burr, Senator
    Harkin who's been a real leader, Senator Murray and my friend
    Senator Hatch as well.
        And now we have the clear recommendations of the
    Appropriations Committee on what is necessary to move ahead.
    The President's request for FDA was $467 million. Senate
    Appropriations recommended $522 million. Not an overly dramatic
    increase, but at least, a very important down payment to
    address food safety. And now we're facing a President of the
    United States who is saying he's going to veto the bill.
        Every family in America that looks to this agency for their
    food safety, that goes down to that market today has to ask,
    What in the world is going on? We're going to give you a chance
    to speak to that, Secretary Leavitt, but before we'll hear from
    our friend, Senator Enzi.

                       Opening Statement of Senator Enzi

        Senator Enzi. Thank you Mr. Chairman. My message will
    probably be a bit more optimistic.
        [Laughing.]
        But I would like to thank the Chairman for working with me
    and working with me in a very bipartisan manner, not just
    recently but for a long time. And it was exactly a year ago
    that this committee held a hearing on bagged spinach because
    there was a national problem with it. It was contaminated with
    E. coli, as the Chairman mentioned, and we wanted to evaluate
    the local, State and Federal response.
        Now I think the most amazing thing that came out of that
    hearing was that we have three agencies that are involved in
    isolating and determining there's a problem and then solving
    the problem. And all of the testimony that we got was a
    tremendous cooperation between three agencies. We never hear
    about that with the Federal Government. But three agencies with
    as few as 30 cases are able to determine that there's a problem
    and get the product pulled off the market. And that's out of
    thousands of daily reports of potential problems. To sort
    through those things and come up with a solution is absolutely
    amazing to me.
        Of course, we also heard a lot about some up and coming
    technologies to improve food safety and of course, I
    particularly noticed that those were developed by innovative
    small businesses. And it's important for us all to remember
    that small businesses are the engine of the economy. They
    represent more than 99 percent of the businesses in this
    country and they employ millions of people. Small businesses
    have a lot to contribute.
        But we also have to keep in mind that their resources are
    not the same as the big companies. We do have to hold big and
    small companies to the same high food safety standards but we
    have to recognize that one-size-doesn't-fit-all when it comes
    to regulation. So there's plenty of work to be done on food
    safety at all levels of business, government and consumers. And
    today we're here to evaluate and assess two new reports about
    import safety and food protection.
        Food safety is an issue that affects all of us. It's not a
    partisan issue. We all want the safest food supply possible.
    It's our shared goal. A goal that requires cooperation and
    teamwork through a very complicated process and we'll examine
    that process today.
        The United States does have one of the best food safety
    systems in the world. I appreciated the Chairman's comments
    about a couple of other countries. Again, there are some
    limited areas where they're doing better and we ought to take a
    look at those and see if that won't improve our system too. But
    we do have the best food safety system in the world. There is
    room for improvement and those improvements can take many
    forms.
        For example, we can address how food becomes contaminated
    in the first place and make improvements in that. We can look
    at the advances in processing and handling the food to prevent
    future outbreaks. We can also improve the testing and
    inspection capabilities. For far too long the number of
    inspectors at FDA has been decreasing even as imports rose
    exponentially and new food safety problems arose. And finally
    we do have to consider whether new authorities are needed to
    respond to those problems that are not detected and corrected.
        I'm pleased the Administration takes these issues as
    seriously as I do. There's a lot to like in Secretary Leavitt's
    report and the FDA Food Protection Plan. However we need to
    carefully review the recommendations in those reports before we
    rush to action.
        I like to say that if something's worth reacting to in
    Congress, it's worth overreacting to. So food safety is
    critical to every American. And it's up to us to make sure that
    we take the time to get it right.
        Senator Kennedy and I just spent 2\1/2\ years working on
    fixing the drug safety system in this country. Half of all
    Americans take a prescription drug daily. One hundred percent
    of them eat.
        I will be studying these reports and details as I work on a
    comprehensive approach to improve the safety of the food we
    eat. Of the 50 suggestions for food safety, many concentrate on
    high priority areas, those most susceptible to problems. Other
    recommendations would provide more transparency on which
    companies and food products are safe and which are not. They
    would establish best practices and provide some incentives--
    kind of a mix of the carrot and the stick.
        When Americans purchase a snack, eat at a restaurant or sit
    down to dinner with their families, they should be able to
    expect that the food they eat will not make them sick. We need
    to restore that faith. And I'm working with my colleagues
    across party lines to develop a comprehensive, effective
    strategy to enhance food safety.
        Senator Kennedy and I began that effort in May working with
    Senator Durbin to establish standards for pet food and set up
    early warning systems for any problems with pet foods to
    improve communication systems about all food recalls and to
    coordinate State and Federal activities on fresh and processed
    produce. Finally our efforts led to the creation of a database
    of instances of tainted food so that the FDA can better track
    patterns of problems and target its limited resources to where
    they're most needed.
        We still have a ways to go. New programs, tools,
    technologies and authority are important and needed. But they
    mean nothing if they don't restore consumer confidence in our
    food supply.
        Again, I thank the Chairman for holding the hearing and for
    the witnesses, particularly the Secretary agreeing to
    participate and I look forward to hearing the testimony today.
    Thank you Mr. Chairman.
        The Chairman. Thank you very much. We've been joined by
    Senator Harkin, Senator Burr, Senator Allard, and Senator
    Murray. I'd like to hear from the Chairman of the Agriculture
    Committee. That committee has interest in food safety and eggs,
    poultry and meat, so I ask Senator Harkin to say a word, then
    Senator Burr if you wanted to speak. I don't want to cut off
    the others.
        We'd like to get to the hearing, but I do think there's a
    special set of circumstances when we have both a member of our
    committee and someone who's involved in the issue of food
    safety as much as Senator Harkin is. So, Tom, we'd be glad to
    hear from you and then I'd be glad to have a word from our
    other side here. And then we'll get on with the Secretary.

                          Statement of Senator Harkin

        Senator Harkin. Thank you very much Mr. Chairman. I
    appreciate the kindness. And thank you very much for you and
    for Senator Enzi for holding this hearing.
        I'll just ask that my statement be made a part of the
    record and I'll just say a couple of things here. I know you
    want to move on and I apologize in advance that I will not be
    able to stay for the whole hearing.
        We have a real crisis of confidence in America today in our
    food safety system. Every day we're reading about all these
    problems. First, we had the E. coli outbreaks last year that
    the Chairman spoke about. One hundred and ninety-nine people
    were sickened. There were 31 cases of hemolytic uremic
    syndrome, a severe kidney disorder, 102 hospitalizations, 3
    deaths. Since then we've had recalls involving pet food, peanut
    butter, lettuce, ground beef, chicken pot pies, pizzas, etc. In
    September, more than a million pounds of hamburger were
    recalled and then just last month another million pounds of
    ground beef were recalled.
        Again, as this committee knows our food safety inspection
    system started years ago with meat and then poultry and then
    eggs. And that was under the jurisdiction of the Department of
    Agriculture, where it remains today in the Food Safety and
    Inspection Service. Later on with the establishment of the Food
    and Drug Administration, other food products came under their
    jurisdiction. So we have a split system now where the FDA has
    everything except meat, poultry and egg products and therein
    lies a problem.
        With meat, poultry and egg products there are slaughter
    plants, facilities, and processing facilities. We have an
    inspection system that dates back to more than half a century.
    It's been modified and updated. But there are basically narrow
    channels through which these products go and inspections can be
    conducted in a fairly good manner.
        Now, since that time we have seen the blending of meat and
    meat products, including meat from other countries that come
    into this country to get blended. That's why we have a problem
    with ground beef all the time. You don't have big problems with
    cuts of meat. Most of the problems are with ground beef blended
    together from different areas. So that's an area in which we
    need to have better oversight and better inspections on the
    part of the Department of Agriculture.
        But then think about how our eating patterns have changed.
    The challenges we face today are broader and more complex than
    they ever have been. Our entire food supply domestic and
    imported, I think, needs to be examined. Fifty years ago we
    gave little thought to problems with fresh produce. That's one
    of our big challenges today.
        So we have changing production methods. We have changing
    eating habits, of course, and different technologies. Now the
    Food and Drug Administration's plan that the Chairman spoke
    about, I'm encouraged by some of it, but I'm very concerned
    that the plan falls well short of a truly comprehensive
    strategy for ensuring the safety of our food.
        The Department of Agriculture and the FDA either need to
    work together more closely in a harmonized, integrated system
    for the safety of our food supply both from farms here to
    dinner plates in this country or from imported food coming into
    this country. Again now with the Department of Agriculture, I
    would say to my friends here, we have an equivalency standard
    for meat, poultry and egg products when we import them from
    other countries. In other words the slaughtering facilities,
    the inspection facilities in other countries must be equivalent
    to our own when it comes to meat, poultry and egg products.
        But when it comes to fruits and vegetables and other foods,
    we have no equivalency standard, none whatsoever. And so, we
    don't know about all these products coming in from other
    countries. I mean every once in a while we detect antibiotics
    in food from China. Once in a while we detect pesticides in
    food. But FDA, right now, inspects, and I could be corrected on
    this, but I think I'm right. FDA inspects less than 5 percent
    of the food coming into this country.
        What kind of assurance is that to our public, when first we
    don't have an equivalency standard and then we inspect less
    than 5 percent of food coming into this country? Because of the
    changing patterns and the huge increase of imported foods
    coming in, the changing patterns and the changing farming
    technologies in our country with produce--fruits, vegetables,
    which we want our people to eat more of because we know it's
    healthy--perhaps it's time to think about a different system of
    inspection. Maybe it is time to think about a single food
    inspection agency charged with responsibility of all food
    inspections.
        I know Senator Durbin has an amendment to the Farm bill
    which we have on the floor. Maybe we'll get to it one of these
    days. But his amendment would sunset the FDA and the FSIS at
    the end of 2010 which means that the next Congress would have
    to do something and come to grips with this issue.
        I don't know. I'm not here to tout his amendment, but quite
    frankly I think it has a lot of promise. I think that there's
    some validity to that approach of saying we're going to sunset
    it and we better come up with something that harmonizes and
    integrates all of our food inspection for domestic and imported
    foods. And maybe sun setting everything would force Congress to
    finally do something which we haven't done yet.
        And so I just say to my Chairman here I look forward to
    working with you and with Senator Enzi, both in my capacity as
    a member of the committee but also as my capacity as Chairman
    of the Agriculture committee to get to a better system that
    harmonizes, that has equivalency standards, that really does
    give better assurance to our people that their food is indeed
    safe. So I look forward to working with you, Mr. Chairman in
    this endeavor.
        [The prepared statement of Senator Harkin follows:]

                      Prepared Statement of Senator Harkin

        I would like to thank Chairman Kennedy and Ranking Member
    Enzi for holding this hearing on developing a comprehensive
    response to food safety. As we all recognize, food safety is of
    critical importance not only to our food and agriculture
    sectors, but also to public health. The results of weak food
    safety oversight are human victims of foodborne illness and
    severe economic consequences to our Nation's food and
    agriculture industry. These problems can be prevented by
    strengthening the Federal Government's ability to ensure a safe
    food supply.
        Today, we have a real crisis of confidence in this country
    when it comes to food safety. Over the last year, the American
    public has been bombarded with repeated recalls and alerts with
    regard to adulterated food. In September of last year, an
    outbreak of E. coli caused by contaminated spinach sickened 199
    people, including 31 cases of Hemolytic Uremic Syndrome--a
    severe kidney disorder. There were 102 hospitalizations, and 3
    deaths. Since then, we've seen recalls involving pet food,
    peanut butter, lettuce, ground beef, chicken pot pies, and
    pizzas. In September, more than a million pounds of hamburger
    patties were recalled because of contamination with E. coli.
    There have been 40 cases of foodborne illness related to that
    recall. Just a little over a month ago, there was another
    million-pound recall of ground beef.
        Now, I am not saying that our food safety system is
    entirely broken. After all, recalls are a normal and necessary
    part of the system. There have been too many, however, and in
    the past year, the authorities have been tardy in catching and
    responding to food-contamination problems. Gaps and lapses in
    the food safety system have human and economic costs.
        As this committee knows, government food inspection got its
    start early in the 20th century with the publication of Upton
    Sinclair's exposes of horrific conditions in the meat packing
    industry. Since Sinclair's day, meat and poultry have been the
    subject of intense scrutiny. But the food safety challenges we
    face, today, are broader and more complex. Today, our entire
    food supply, domestic and imported, needs to be examined. Fifty
    years ago, we gave little thought to the safety of fresh
    produce, but that is one of our challenges today. It is time
    for our laws and regulations to be changed to reflect changing
    production methods, eating habits, and technologies.
        The Food and Drug Administration (FDA) released a ``Food
    Protection Plan,'' which it describes as ``an integrated
    strategy for protecting the Nation's food supply.'' I am
    encouraged by some of the recommendations and action items the
    Plan addresses. But I am very concerned that the Plan falls
    well short of a truly comprehensive strategy for assuring the
    safety of our food. The Department of Agriculture (USDA) and
    FDA must work closely together towards a harmonized, integrated
    strategy for our entire food supply, from farm to fork instead
    of fixing problems in a piecemeal fashion for a portion of our
    food supply. There are very good reasons for the differences
    between how USDA and FDA regulates the food supply. However,
    most of those differences have more to do with history than
    science. Congress, government agencies, consumers, and the food
    and agriculture sector must work together to modernize our food
    safety system with the best available science to prevent
    further losses in consumer confidence, and most importantly, to
    prevent the loss of human lives. This is an enormous
    undertaking, but as a member of this committee and in my role
    as Chairman of the Agriculture, Nutrition and Forestry
    Committee, I am committed to working on this issue of critical
    importance to consumers and to American agriculture.
        The Chairman. Senator Burr, if you'd want to make a
    comment.

                           Statement of Senator Burr

        Senator Burr. Mr. Chairman, I'll be extremely brief because
    as I heard your points that you got from the Scientific
    Advisory Committee, I'm not so sure I found it a condemnation
    of FDA as I did the American education system because we're
    falling deficient in educating the talent that we need in the
    future, especially as the pool of scientific brain power begins
    to be attracted by more than just the Federal Government.
    Everybody runs short of what they need. So I think we're going
    to do as much good by making sure we fix education as we are by
    orchestrating something that Congress believes the FDA should
    or shouldn't do or creating a new agency.
        Let me just implore my colleagues. Let's give the FDA a
    chance. The Secretary asked for these comments. He got the
    comments. I found him always to be one that acts when he's
    presented with information that's valuable to the agencies. I
    think he deserves a chance.
        Unfortunately we can't point at food safety and just look
    outside our borders and say there's our problem. Our problems
    have been inside our borders before. And it means collaboration
    between the Federal Government and private sector companies.
    That collaboration has started. We've got to see whether it can
    grow into a defense mechanism that truly is one that we can all
    be proud of and more importantly, that we can trust the system.
    And I look forward to hearing the Secretary.
        The Chairman. Well, Senator Allard.

                          Statement of Senator Allard

        Senator Allard. Mr. Chairman if I might just make a brief
    comment here. As a veterinarian I've had the experience of
    actually doing food inspections. I belong to a profession who a
    good deal of those members are active in the FDA and the
    Department of Agriculture on food quality. And I would just
    have to say that my personal view is that I think we shouldn't
    lose our perspective here.
        The American food supply is the best quality and the safest
    in the world and that's because we do a lot scientifically. We
    do a lot diagnostically to recognize problems. And then we
    adjust that using good science and as a result, we tend to
    report problems that don't get reported in other countries. And
    we have a good quality food supply here. I don't think we
    should forget that perspective.
        Now, do we have problems? Sure, we have some problems. But
    I think we have to keep a proper perspective in this. And I
    would agree with Senator Burr. A lot of this is educational.
    You know, if you have E. coli in hamburger, just make sure your
    hamburger is well cooked. That will take care of the E. coli
    problem. You don't need to have books and books of rules and
    regulations on E. coli.
        The American public needs to understand that there's
    different types of E. coli. There's E. coli that's normal in
    your bowel. There's E. coli that causes disease. And they need
    to understand that.
        So, I see a big need for improving our educational effort.
    We need to continue to look at diagnostic ways in which we can
    monitor food to make sure it is safer. And we need to make sure
    we have the proper balance of enforcement and proper education.
        So I'm looking forward, Mr. Chairman, to the comments from
    the Secretary to understand what the FDA is doing and how
    they're managing this and how they're responding to these
    reports. And so, this is a very timely hearing. And I want to
    complement you, Mr. Chairman for holding this hearing and
    working with Senator Enzi. I think you make a great team on
    this committee. And this is an important issue, something I'm
    interested in. Thank you.
        The Chairman. Thank you very much. Mr. Secretary, we look
    forward to your comments. You've heard from us. We want to hear
    from you. Welcome.

      STATEMENT OF HON. MICHAEL LEAVITT, SECRETARY, DEPARTMENT OF
    HEALTH AND HUMAN SERVICES, WASHINGTON, DC.; ACCOMPANIED BY DR.
            DAVID ACHESON, DEPUTY COMMISSIONER, FOOD SAFETY

        Secretary Leavitt. Well, thank you, Senator. I'm going to
    acknowledge that I'm here with David Acheson, who is the Deputy
    Commissioner for Food Safety. I may call on him at various
    points for technical advice.
        May I just acknowledge that the American people have high
    expectations of quality and safety and they ought to? And I
    acknowledge that my wife and I, my children, my grandchildren
    all eat from the same food supply you and other members of the
    Senate do. We have a very serious personal interest in this
    being well developed. I would like to also associate myself
    with those who have acknowledged that our food supply is among
    the safest in the world.
        We have a good system. It is not adequate for the future.
    And I believe that's what this hearing is about. It's about how
    do we take what we have and there's an old saying in the hockey
    world, ``you have to skate where the puck's going to be.'' How
    do we create a system for the 21st century that will
    accommodate the very basic changes that are beginning to change
    our market?
        Over the course of the last several months as you have
    suggested, I've seen sea ports, I've seen freight hubs at
    border crossings, wholesale, retail, processing of food, drugs.
    I've inspected everything from tire irons to gingerbread
    houses. I've had a chance to see a pretty good fraction of this
    on 300 ports of entry for imports. I've been able to get a
    sense of how big this is. And it's clear to me that we have
    seen warning signs in the last several months that our current
    system is not keeping up and we have to respond.
        I'd like to also point out that this is not an issue that
    we are facing uniquely in the United States. About a month ago
    I had the Ministers of Health and Food from eight of the
    largest industrial countries in the world come to the United
    States including the European Union. Every one of them are
    dealing with this issue in the same way we are. Why, because
    something very basic has changed. We're now in a global
    marketplace.
        I had a meeting in a grocery store some weeks ago, a couple
    of weeks ago. I met a man named Dan who was the produce
    manager. Dan told me that he had been in the produce business
    for some 30 years. I'd asked what has changed most. He said,
    ``it's what the customers want.'' They want to have fresh
    strawberries in January. They want blooming sunflowers in
    November. And we can give it to them. But we now operate in a
    global market.
        So, what's changing here? The reason we're seeing these
    warning signs is because our system, while good, is not
    adequate for the future and it does not allow us, at this
    point, to respond to those needs. And we need to change it.
        I think appropriately the President responded to those
    warning signs and asked that a group of his Cabinet--he
    appointed a working group. He appointed me as Chairman. I think
    it's an important point.
        I'd like to just read the list of the Departments in the
    Federal Government that are involved in this because it, I
    think, demonstrates that this isn't just about the FDA or the
    Department of Agriculture. This is a government-wide, society-
    wide task that requires a coordinated and collaborative
    approach. HHS, the Department of State, there's a lot of
    international relationships involved here. The Department of
    Treasury, the Department of Justice, the Department of
    Agriculture, the Department of Commerce, the Department of
    Transportation, the Department of Homeland Security, the Office
    of Management and Budget, the Trade Rep, the EPA, the Consumer
    Product Consumer Commission, all of these have a very important
    role in how we develop a 21st century system of import safety.
        Now I hope we get a chance to talk about the report today
    some. I'd like to just summarize it if I could. I recognize
    that the time is somewhat limited. I'd like to give you my
    impressions after having been in, I think, a fairly sizable
    fraction--seeing a sizable fraction of the system firsthand.
    First, it is so large we will never inspect ourselves to
    safety. We simply have to change our strategy. Rather than try
    to inspect everything that comes across our borders and stand
    at the border and simply try to catch things as they come. We
    need to begin building quality into the system every step of
    the way.
        Now, I met the manager of a lettuce processing plant out in
    Texas. He said to me, ``our motto here is you need to know your
    grower.'' I said, ``what do you mean?'' He said, ``I want to
    know where that lettuce came from. I want to know who planted
    it. I want to know what nutrients they put on it. I want to
    know the quality of the water they used. I know when they
    picked it. I want to know how it was treated after it was
    picked. I want to know who shipped it. In other words I want to
    see that quality was put into that product every step of the
    way.'' That's the future, in my judgment, building quality in.
        Now, we divided our task, given to the President to take an
    overall look at this system, into two parts. The first is we
    took all of those Departments and developed teams and made very
    deep looks into every one of those departments and asked
    questions that I think, you would have asked, Senator. What are
    the authorities that you currently have? Are they adequate?
    What are the changes that we need to be responding to? Do you
    have the authority and the budgets that are necessary? What
    kind of limitations do you have right now that need to be
    overcome? What do you need to do the job?
        I then fanned out and went, as I mentioned, I went to over
    30 different places and saw, I think, the totality of this
    system. The good news is that the themes that began to boil up
    from our deep look into the government response and began to
    match those that we found in the field. We came back with a
    report. There are 50 specific recommendations within 14
    different categories.
        Now I won't take the time to go through all of them. Let me
    just give you seven or eight brief headlines that I think will
    populate our conversation. The first is the need for us to have
    a stronger certification process. It's my view that products
    need to be not just inspected, we need to assure that the
    process that's being used to provide safety has been inspected
    by somebody we trust.
        Now in some cases that's an FDA inspector or a Department
    of Agriculture inspector or someone from the Customs and Border
    Protection. In other cases it might be an independent
    certifying body. For example, many of us are familiar with the
    Good Housekeeping seal of approval. When we see that seal we
    feel confident because we can trust them. We see Underwriter
    Laboratories. Those are independent inspections. When they're
    on it we assume that they have looked through and we can have
    confidence in it. There are other independent inspections that
    if the government has accredited them we could use to expand
    what the current system has.
        Now there was a blue uniformed FDA agent who taught me this
    lesson. He said, ``Mr. Secretary, our job is like finding the
    needle in the haystack. Our first job is we've got to shrink
    the haystack. We've got to use certification processes to
    figure out who the bad actors are and who the good ones are so
    that we can concentrate on where the trouble's going to be.''
        His point, I think, that leads to the second point I wanted
    to make in addition to certification. We need to promote good
    importing practices. We need to make it harder for people to
    get goods into this country if they don't follow the rules. And
    we need to make it easier for those that do.
        The third point is greater transparency. People deserve to
    know who it is that imports safe products and those that don't.
    We need to give people their names. Why is that important? Time
    after time I've had members of the retail community say, ``I'm
    telling my suppliers, before you can put something on my shelf,
    I want to know it's safe because my reputation is at stake.''
    We need to tell retailers and consumers who those people are so
    that the marketplace has a chance to do its magic on this
    problem as well.
        Increase presence overseas. We need to have more U.S.
    personnel in exporting areas or in ports so that we're able to
    not only look at goods before they come, but we can use their
    presence there to teach people how to meet our expectations. We
    need to build this into our trade agreements. We need to have
    physical inspections as well.
        Stronger penalties, higher standards, better systems. We
    did find places where our systems are deficient. They need to
    be improved. For example, FDA inspectors over and over tell me
    that we have five passwords on our system that I have to
    remember because I can't get all of the information I need from
    one screen.
        I had members of the Customs and Border Patrol tell me we
    have seven different passwords that we need to receive and
    sometimes they can't get the information between them. There
    are times that the FDA can't get the information that's
    necessary from the Department of Agriculture. That's a problem
    we need to respond to.
        The President recently issued an Executive order requiring
    all the Federal agents to come together to create interoperable
    systems. We need to have faster response tools. And these are
    happening.
        I was in a grocery store in the Midwest. I asked them about
    their recall. They told me some impressive stories about the
    way our recall system works. I might add, the fact that we have
    recalls doesn't entirely mean we've had a failure. It means the
    system found something and we're responding.
        We have systems in most major retail outlets in this
    country that if a retail product is known to need to come off
    the shelf, it can happen in a matter of hours. They can shut
    the cash registers down where no more products can get out
    until they can get the product off the shelf. They're now
    moving to a point where they can use their value cards and the
    various communications vehicles they have with their systems to
    notify customers. One grocery store told me that they can now
    identify a canned good or some kind of produce item that was
    sold in a previous period and within literally, minutes,
    contact as many as 2 million consumers who may have in fact
    purchased that product.
        So, just to summarize, a change in strategy, Mr. Chairman,
    needs to occur. We can't just stand at the border and hope to
    catch things as they come in. We have to build quality in every
    step of the way. We need to have stronger certification
    processes. We need to promote better import practices.
        Reward those who follow the rules, punish those that don't.
    We need to have transparency where consumers know who it is
    that produces a safe product and who doesn't. We need to have
    an increased presence overseas, enhanced standards, stronger
    penalties. We need to have better interoperable systems and we
    need to have faster tools of response.
        Now you raised the point about budget. And I'd like to talk
    a little bit about our response in the report. The report makes
    very clear that this will require more resources. We chose not
    to try to replicate the entire budget process because there are
    12 different departments involved. And if we were to try to put
    what the amount is in the report we would essentially be
    replicating that process.
        Every budget that we have put forward in the last 3 years
    while I've been involved has asked for more resources. Our
    current budget will as well. So there's no question that
    building that system for the future will require investment.
        Mr. Chairman, I look forward to having this discussion. I
    hope it's robust and it's complete. As I mentioned, my wife and
    I, my children, my grandchildren, all eat from the same food
    supply that committee members do and the American people
    deserve to have these expectations and we need to meet them.
    Thank you.
        [The prepared statement of Secretary Leavitt follows:]
                    Prepared Statement of Michael O. Leavitt
        Chairman Kennedy and members of the committee, I am pleased to be
    with you today to discuss the Action Plan for Import Safety. The Plan,
    which I delivered to the President on November 6, puts us on the verge
    of a major transformation in the way we view imported consumer products
    and assure their safety. At the request of the President, I chaired the
    interagency working group on import safety which included
    representatives from 12 Departments and Agencies. The Plan was
    developed following a careful examination of import product safety
    issues, and it contains 14 broad recommendations and 50 short- and
    long-term action steps that will enhance the safety of imports entering
    the United States for the 21st Century. Today I want to cover some of
    the key elements of the Action Plan and explain our strategy for
    implementing them.
        First, it is important to mention why this effort is so important
    and the challenges involved. Today, Americans import approximately $2
    trillion worth of goods from over 800,000 importers through 300 ports
    of entry. The growth in the volume of imports over the last two decades
    has been nothing less than astounding and it shows no signs of slowing.
    The expansion of imports is driven by growth of trade in a global
    economy. There are many benefits to consumers. A wide variety of fresh
    fruits and vegetables, seafood, and a range of ethnic and other foods
    from foreign countries are available year round in our grocery stores
    in a way that our parents could not have imagined. International trade
    provides Americans access to innovative products and productivity
    enhancing technologies from other countries which add to our quality of
    life.
        Imported products are generally safe in the United States and
    Americans enjoy one of the safest food supplies in the world. Yet, we
    are all aware of recent incidents with unsafe toys and tainted pet
    foods from China. In addition, there have been concerns about the
    safety of imported drugs. These incidents of unsafe imports raise
    legitimate concerns. However, we should not conclude that imports are
    unsafe or that all products from China or other countries are to be
    avoided. Instead, these incidents point to the need to revamp the way
    we deal with import product safety. To put it another way, imports are
    safe today but, due to the high volume of trade, we need to transform
    the import system and change the way we verify product safety to meet
    the challenges of a global economy.
        This problem is not unique to the United States. I have raised
    these issues with the ministers of health from eight of our closest
    trade partners, and they all have the same concerns. The growth of the
    global economy has created new challenges for ensuring the safety of
    imported products. Some of these challenges are: the large and growing
    volume of imported products; the large number of ports of entry and the
    need to process imported products quickly at the ports; the increased
    volume of imports from less developed countries; the complexity and
    variety of products which carry increased risk; and, the need for
    stronger safety and quality standards around the world. Further, as
    global trade has grown, so has the value of trade and the opportunity
    for unscrupulous businesses to short circuit safety standards or engage
    in the sale of counterfeit products. Our 20th century approach to
    ensuring import safety of attempting to screen products at the border
    is a ``snapshot'' approach that will not work for the 21st century. The
    Federal Government cannot, and should not, attempt to physically
    inspect every product entering the United States This is like trying to
    find the needle in the haystack. The Action Plan we are discussing
    today addresses this challenge.
        Now, let me turn to our Strategic Framework for enhancing import
    safety and some key elements of the Action Plan. The organizing
    principles fall into three major areas: prevention, intervention, and
    response, and we have a number of recommendations and specific short-
    and long-term action steps in each of these areas.
        Our overall goals are to:

         Promote a common vision of import safety with our trading
    partners and foster a culture of collaboration;
         Focus on risks over the product life cycle rather than a
    snapshot at the border;
         Increase accountability, enforcement and deterrence;
         Build interoperable data systems and encourage data
    sharing; and
         Promote technological innovation and develop new tools to
    enhance import safety.

        The Action Plan covers all imported consumer goods that could pose
    a potential safety threat to U.S. consumers--from toys and tires to
    drugs, medical devices, dietary supplements, cosmetics, and all foods
    for both humans and animals. The general thrust of the plan is to
    broaden our focus from examining products as they enter the United
    States to monitoring imported products throughout their life cycle from
    production to consumption, paying particular attention to the critical
    points of risk along the way where safety can be compromised and safety
    standards are most needed.
        Some of the highlights of the Action Plan are:

         Creating new and strengthening existing standards. We will
    work with international standard-setting organizations and foreign
    government regulators around the world to develop international
    standards that reflect the same level of protection maintained for
    consumer products in the United States.
         Verifying compliance with safety standards. We are
    proposing a voluntary certification program whereby products could be
    certified as meeting U.S. safety standards. This may involve
    verification--for example, testing or inspection by third parties or by
    domestic or foreign regulatory bodies. In addition, if HHS is provided
    the necessary authority, importers of certain high risk products could
    be required to certify that those products meet certain standards
    before they are exported to the United States.
         Encouraging Good Importer Practices. Import guidance
    documents will be developed to encourage the adoption of best practices
    to improve import safety.
         Enhancing enforcement. While voluntary product recalls are
    usually adequate to protect consumers, we are recommending authority
    for mandatory recall for the FDA in certain instances.
         Expediting consumer notification of product recalls. Track
    and trace technologies will enable officials to pinpoint where the
    problem occurred and intervene quickly. In addition, other technologies
    such as integrated circuit cards, also known as Smart Cards, may allow
    retailers to notify consumers of potential safety problems.
         Exchanging import data. U.S. Customs and Border
    Protection, the FDA, USDA and other agencies will increase coordination
    with real-time sharing of product safety information to better inform
    decisions about clearing or rejecting import shipments. In addition, we
    are exploring ways to expand the sharing of key data with foreign
    governments, consistent with applicable law, and gaining more access to
    data existing in the private sector as well.
        The 12 Departments and Agencies involved in the generation of the
    Action Plan each have a role in the implementation of its
    recommendations. We also anticipate involvement of private sector
    stakeholders--retailers and manufacturers, importers, consumer groups,
    and others. Many of the Action steps can be accomplished by
    administrative changes, but some will require changes in the law and we
    are looking forward to working with Congress to accomplish these.
                            fda food protection plan
        Earlier this year, I directed the FDA Commissioner to develop and
    submit to me a comprehensive plan for protecting the Nation's food
    supply. This plan, the FDA Food Protection Plan, was released at the
    same time that I submitted the Action Plan for Import Safety to the
    President. It utilizes the same framework as the Action Plan:
    Prevention, Intervention, and Response, and its action steps are
    consistent with and complementary to the recommendations of the Action
    Plan. One distinction is that the Food Protection Plan applies to
    domestic food producers as well as all imported foods regulated by the
    FDA. I would now like to provide an overview of the Food Protection
    Plan.
    Prevention
        Prevention is the first essential step for an effective, proactive
    food safety and defense plan. There are three key prevention steps: (1)
    promote increased corporate responsibility to prevent foodborne
    illnesses; (2) identify food vulnerabilities and assess risk; and (3)
    expand the understanding and use of effective mitigation strategies.
    The prevention steps are risk-based and will be implemented as
    appropriate to particular segments of the industry.
        First, to promote increased corporate responsibility, we must
    strategically place greater emphasis on preventive measures for food
    safety and food defense. These measures will promote improved food
    protection capabilities throughout the food supply chain. This will
    require close interaction with growers, manufacturers, distributors,
    retailers and food service providers, and importers. FDA will continue
    to work with industry and State and local governments to further
    develop the tools and science needed to identify vulnerabilities and
    determine the most effective approaches. With regard to imports, we
    will work with foreign governments, which have a greater ability to
    oversee manufacturers within their borders to ensure compliance with
    U.S. safety standards.
        New authorities will be needed to accomplish this first goal. For
    example, the Food Protection Plan outlines new authorities to require
    entities in the food supply chain to implement measures solely intended
    to protect against intentional contamination of food by terrorists or
    criminals at points of high vulnerability. We have also proposed
    authority to issue regulations in certain circumstances requiring that
    high-risk foods be prepared, packed, and held under a system of
    preventive food safety controls.
        Second, to identify food vulnerabilities and assess risk, we will
    work with the food industry, consumer groups, and Federal, State,
    local, and international partners to generate the additional data
    needed to strengthen our understanding of food safety and food defense
    risks and vulnerabilities. A comprehensive, risk-based approach will
    maximize the effectiveness of its available resources by focusing on
    food products that have the potential to pose the greatest risk to
    human and animal health. By analyzing data collected throughout the
    food product life cycle, we are better able to detect risks posed by
    food products. We are also better able to recognize key junctures where
    timely intervention can reduce or avoid those risks. Working with the
    Centers for Disease Control and Prevention (CDC), FDA will also build
    the capacity to attribute pathogens to specific foods and identify
    where in the production life cycle the foods became contaminated. When
    established and emerging risks are identified, assessed, and ranked, we
    are able to more effectively allocate our available resources to manage
    these risks.
        Third, in order to expand the understanding and use of effective
    mitigation strategies, we will initiate additional risk-driven research
    about the sources, spread, and prevention of contamination. We will
    also develop new mitigation tools and implement appropriate risk
    management strategies. Building on risk assessments, we will initiate
    basic research to enhance our understanding of sources of
    contamination, modes of spreading, and how best to prevent
    contamination. This information will inform FDA's efforts to promote
    increased corporate responsibility to implement effective preventive
    steps. Focusing on higher risk foods, we need to increase research and
    leverage relationships with outside organizations in order to develop
    new methods to detect contaminants in foods, and seek to facilitate new
    technologies that enhance food safety.
    Intervention
        Because no plan will prevent 100 percent of food contamination,
    targeted, risk-based interventions are needed to provide further
    protection. The Food Protection Plan includes ways to focus on
    inspections and sampling based on risk, enhance risk-based surveillance
    and improve the detection of food system signals that indicate
    contamination.
        However, the universe of domestic and foreign food establishments
    subject to FDA inspection is immense and continues to increase.
    Therefore, legislation is needed to authorize FDA to accredit or
    recognize and use highly qualified, independent third parties to
    evaluate compliance with FDA requirements, thereby allowing the
    Agency's resources to be more effectively allocated. Use of accredited
    third parties would be voluntary and might offer more in-depth review
    and possibly faster review times and expedited entry for imported goods
    manufactured in facilities inspected by accredited third parties. FDA
    would not be bound by these third-party inspections in determining
    compliance with FDA requirements. However, use of accredited third
    parties could be taken into consideration when setting inspection and
    surveillance priorities.
        To enhance the Agency's risk-based surveillance, we plan to focus
    on improving our ability to target imported foods for inspection based
    on risk through the use of advanced screening technology at the border
    and enhanced information sharing agreements with key foreign countries.
        Also, as part of the fiscal year 2008 budget, the Administration
    proposed a new user fee requiring manufacturers and laboratories to pay
    the full costs of re-inspections and associated follow up work when FDA
    reinspects facilities due to failure to meet current Good Manufacturing
    Practice (cGMP) or other FDA requirements. Where FDA identifies
    violations during an inspection or issues a warning letter, FDA
    conducts follow up inspections to verify a firm's corrective action.
    The proposed fee ensures that facilities not complying with health and
    safety standards bear the cost of reinspection.
        Further, we recommend the option of moving the inspection of high-
    risk products of concern ``upstream'' by entering into agreements with
    the exporting country's regulatory authority for that entity (or an
    FDA-recognized third party inspector) to certify each shipment or class
    of shipments for compliance with FDA's standards prior to shipment. FDA
    would apply this requirement to imported products that have been shown
    to pose a threat to public health for U.S. consumers. While FDA would
    retain the authority to verify the safety of imported products, this
    approach shares the burden of ensuring the safety of food products with
    the exporting country. For such a system to be effective, we will have
    to establish an in-depth collaboration with the relevant foreign
    government authority to ensure that the standards, processes, and
    criteria by which the foreign authority or third party is certifying
    products are consistent with FDA's. The Agency will also have to take
    several steps to ensure a secure system that prevents counterfeiting of
    the certificates and takes into consideration trans-shipment of
    products as a way to avoid certification. FDA would use
    nondiscriminatory, scientific, and risk-based criteria to determine the
    focus of this proposed authority.
        As noted earlier, improving the detection of food system
    ``signals'' that indicate contamination is an important component of
    enhancing our intervention capabilities. We can better detect and more
    quickly identify risk ``signals'' in the food supply chain by deploying
    new rapid screening tools and methods to identify pathogens and other
    contaminants and by enhancing our ability to ``map'' or trace adverse
    events back to their causes by improving the Adverse Event and Consumer
    Complaint Reporting System. This additional information will serve as a
    supplemental warning indicator for trending emerging food protection
    problems.
        The recent pet food recalls showed us that we must continue to
    focus our efforts on animal as well as human food. For example, to
    provide the information necessary to allow for early detection of, and
    intervention with, contaminated pet food, FDA will work with the
    veterinary community, veterinary hospitals, and other private sources
    to develop an early warning surveillance and notification system to
    alert veterinarians and others about problems with the pet food supply.
    Response
        To improve our immediate response, we will work with stakeholders
    to develop an action plan for implementing more effective trace-back
    process improvements and technologies to more rapidly and precisely
    track the origin and destination of contaminated foods, feed, and
    ingredients. We will also increase collaboration with foreign, Federal,
    State, and local partners to identify a contamination source, remove
    contaminated products, and implement corrective actions.
        Another key component of improving FDA's response is additional
    authority for emergency responses. The Food Protection Plan recommends
    requesting mandatory recall authority and enhanced access to food
    records during emergencies. This recall authority would be used only
    when the current voluntary recall process fails to promptly remove
    foods that present a threat of serious harm to humans or animals.
    Although FDA has the authority to seize adulterated or misbranded food,
    this is not the most efficient option when the contaminated product has
    already been distributed to hundreds or thousands of locations. And
    while FDA has been able to accomplish most recalls through voluntary
    actions by product manufacturers or distributors, there may be rare
    instances in which a firm was unwilling to conduct a recall. In such
    situations, FDA needs the ability to require a firm to conduct a recall
    to ensure the prompt and complete removal from distribution channels of
    food that presents a threat of serious harm to humans or animals. This
    authority would be limited to foods that the Secretary has reason to
    believe are adulterated and present a threat of serious adverse health
    consequences or death. It would be imposed only if a firm refuses or
    unduly delays a voluntary recall. An order to recall food could only be
    issued by the HHS Secretary, Deputy Secretary, or Commissioner of Food
    and Drugs, and would be accompanied by appropriate due process rights.
        We are also seeking authority that would give the FDA more complete
    and streamlined access to records necessary to identify the source or
    cause of foodborne illness and take needed action during food-related
    emergencies. Improved access to information concerning the safety and
    security of food, including records related to an article of food or
    related articles of food that may present a threat, will enhance FDA's
    ability to identify problems, respond quickly and appropriately, and
    protect public health. The requirement would not impose any new
    recordkeeping burdens and would maintain the current statutory
    exclusions for the records of farms and restaurants.
        Currently, access to records under section 414 of the Federal Food,
    Drug, and Cosmetic Act (FD&C Act or the act) is limited to instances
    where, for an article of food, FDA has a reasonable belief that the
    food is adulterated and presents a threat of serious adverse health
    consequences or death. FDA proposes to expand access to records of
    related articles of food, such as food produced on the same
    manufacturing line. FDA also proposes, in food-related emergencies, to
    remove the adulteration requirement to allow its inspectors access to
    records in emergency situations where FDA has a reasonable belief that
    an article of food presents a threat of serious adverse health
    consequences or death.
        As we continue to move forward with the Food Protection Plan, we
    will work with other Federal agencies, State, local, and foreign
    governments as well as industry to develop the food science and tools
    necessary to better understand the current risks of the food supply,
    develop new detection technologies, and improve response systems to
    rapidly react to food safety threats.
                             u.s.-china challenges
        Now I want to turn to the issue of imported products from China. As
    I have mentioned, although there have been some recent problems with
    Chinese imports, we must not conclude that all products made in China
    are dangerous. However, as noted below, we are currently taking a
    number of steps to improve the flow of information on the risks of
    imports from China and efforts will be made to increase the safety of
    Chinese imports through certification of quality controls in goods
    produced in China for export.
        Let me provide some context for the discussion. China has a complex
    product safety regulatory system that consists of the Ministry of
    Agriculture which monitors food production and regulates farm inputs;
    the General Administration of Quality Supervision, Inspection and
    Quarantine [AQSIQ] which monitors processing and trade, the
    Certification and Accreditation Administration, which regulates the
    production certification, and the State Food and Drug Administration
    [SFDA] which coordinates food and drug policies and investigates safety
    mishaps. The Chinese system is challenged by rapid growth and
    decentralization of power which has resulted in overlapping authorities
    in some areas and gaps in regulatory control.
        I have met with Chinese officials on several occasions to discuss
    import regulatory issues and we are in the process of finalizing
    negotiations on two binding Agreements that we expect to sign soon. One
    will cover the safety of food and feed, and the second will cover the
    safety of drugs and medical devices. These agreements outline the
    processes and points of contact for both countries to follow when the
    importing country rejects a shipment.
        We expect that the provisions of the Action Plan will be
    instrumental to improving the safety and bolstering consumer confidence
    in Chinese imports.
                                   conclusion
        Implementing the Import Action Plan and the Food Protection Plan
    will require resources, including reallocation of existing resources,
    as well as trade-offs, to fund these priorities. We plan to coordinate
    with Federal departments and agencies to carefully plan the
    implementation and submit funding needs through the normal budget
    process in February 2008 and in subsequent years. To the extent that
    additional statutory authority is needed to implement the Import Action
    Plan, we look forward to working with this committee on import product
    safety legislation.
        U.S. imports are large and growing rapidly. American consumers like
    the variety and abundance of consumer goods and the competitive prices
    that result from global trade.
        The American people, however, have reasonable expectations that the
    products they buy for their families will be safe. We can and must do
    more to honor that trust.
        The Action Plan will lead to both short- and long-term improvements
    in the way we view and regulate imported consumer products and
    implementing these recommendations will enable us to meet the
    additional safety challenges of imports in the 21st century. We
    appreciate the support of this committee and Congress as we move
    forward with our recommendations.
        Thank you for the opportunity to discuss this important topic. I
    will be pleased to respond to your questions.

        The Chairman. Well, thank you very much, Mr. Secretary. And
    I was looking through your report earlier and it has the
    features that you've mentioned here. I looked at it in terms of
    prevention and what's happening, currently. The authority you
    need to deal with the challenges that you're facing, and you've
    reviewed those.
        I'm concerned about the current situation. As I'm looking
    down the road I wonder how we're going to be able to build in
    the future if we haven't got the underpinnings we need out
    there at the present time. The advisory committee has
    questioned the whole scientific workforce and infrastructure,
    the underpinnings, when it describes the agency not having
    adequate investment in information technology and the use of
    antiquated equipment out there at the FDA.
        And having to bring in people who have retired in order to
    repair equipment at the agency because it's so antiquated. And
    that the total number of inspectors is down, and the
    difficulties and challenges getting the kind of scientific
    workforce the agency needs. I agree that we have educational
    issues, and we have to work on those matters.
        But the core factor about the agency and it being able to
    function is money. Money doesn't solve everything, but it is an
    indicator of a nation's priorities.
        I think the commissioner of FDA is to be commended for
    requesting a review about where the agency is and what it
    needs. I mean, that's a bold request. It could have been done
    in house. And I think if it had been done in house, a lot of
    this would have been smoothed over. But, as it is, we have very
    distinguished individuals on that advisory committee and they
    have pointed out the extraordinary challenge that the agency is
    facing.
        How are we going to look at the future when you've got the
    underpinnings that are crumbling now? It does seem to me we've
    got the central challenge now, to be able to look down the road
    at how we're going to coordinate different kinds of inspections
    in the future.
        We have to talk about the condition of the underpinnings,
    which this report has put out and examined. And when you've got
    these kinds of conclusions, we would expect to hear from you
    that the FDA does not have the capacity now to ensure the
    safety of the food of the Nation. We can't worry about where
    we're going to be in 10 years when the report indicts the
    current situation. The report says, ``does not.'' It doesn't
    say, ``didn't have'' or ``will not.'' It says, ``does not have
    the capacity to ensure the safety of food for the Nation.''
        Now, there are a lot of good things that are happening at
    the FDA, and some of them have been mentioned in the course of
    this morning's hearing. But, when you have an FDA that does not
    have the capacity to ensure the safety of food of the Nation,
    and the report has specific findings about how the scientific
    base is eroded, how scientific organizational structure is
    weak, and about weaknesses in the workforce and in information
    technology.
        It would seem to me that we have to get that in shape to be
    able to build the follow up that you have talked about in your
    testimony. And we can get into some of those matters as well in
    the time that I have left. But, I would think the American
    people would want a sense of urgency from their person leading
    the agency, a sense of urgency about how you're going to
    respond to the effective indictment in the report. I think
    that's what they're waiting to hear. And I want to give you an
    opportunity to address it.
        Secretary Leavitt. Well, thank you Senator. Well, I think
    the response is right here.
        The Chairman. That's not the current situation.
        Secretary Leavitt. Oh, yes it is. It is very much the
    current situation. We're implementing major parts of this.
        This Friday I will leave for example, for China where I
    will sign agreements that we've negotiated with the Chinese
    that will move us a great step forward in being able to deal
    with the challenges of importing from China and other parts of
    the world. We're already in the process of developing a system
    I've spoken of. We're implementing this strategy.
        What we have now for the first time is, we've taken a
    comprehensive look at the system. We have a clear plan to move
    forward. We have an action plan that not only includes the FDA,
    but includes 12 different departments and agencies of the
    Federal Government and a comprehensive way to go about it.
        And we're reaching out to the private sector. It will not
    be government alone. It's going to require a coordinated
    effort. The urgency, we could not be responding more urgently.
    I'm spending a very high percentage of my time as it goes from
    the other departments to make certain that this is driven
    forward.
        And we're looking forward to working with you in assuring
    that the legislative authorities that are necessary to make
    this work are in place.
        The Chairman. Well, you might have that new, fancy system
    on papers but, you have an FDA that has broken information
    technology equipment today. You can get the most dramatic
    system on paper and it ain't going to work, it ain't going to
    work. And this advisory committee went to the core, to the
    basics, about what that agency needs. What is going to be
    necessary out there to do the job?
        And what's in this report is nothing new. Many of us who've
    been following this agency and have been out to the agency,
    have seen this for ourselves. I haven't been out there for 2 or
    3 years, but I've been out there. And at that time these same
    points could be made as are made by this independent,
    scientific report.
        You can have all of these other actions that you're talking
    about internationally. My time is expired, but I will try and
    get back to question you about them. But if we don't deal with
    what this scientific advisory board says now, we are betraying
    the commitment that the agency has to the American people to
    protect them and their food supply.
        Senator Enzi.
        Senator Enzi. Thank you Mr. Chairman. And I want to thank
    the Secretary for his usual, very concise, well laid out
    presentation. I'm always impressed with that and impressed with
    the results that he gets from his agency.
        I think it's important with all of these discussions that
    we don't move people into a state of fear that we keep them in
    a state of education or in the State of Wyoming, either one.
        [Laughter.]
        When I was first elected Mayor, one of my first visitors
    was a food inspector. And from the discussion I had with him I
    was under the impression that it was my job to go around to the
    restaurants with him and to see what sorts of things he was
    finding there. As an accountant I should have known that the
    job of a person like that is to find the bad things and to find
    as many of the bad things as possible because their job is
    prevention. And I went with him and he did a good job. And I
    didn't eat in a restaurant for several months.
        There are a lot of things behind the scenes that are being
    taken care of. They have to be found first and yes it does take
    people and it takes knowledge and it takes training and it
    takes money in order to be able to do that. And I have some
    confidence that the agency will do that.
        You mentioned that you're going to be going to China and
    working on a Memorandum of Agreement with them on import
    issues. I'm pleased that you're going to do that. What do you
    hope will come out of those discussions? What sorts of things
    can be covered by a Memorandum of Agreement?
        Secretary Leavitt. We're sending a very clear and
    unequivocal message to any country or any organization that
    desires to import goods into the United States for American
    consumers. If they want access to American consumers they need
    to produce goods that are meeting the safety requirements of
    the United States and the quality requirements of the United
    States.
        We want them to have access to our markets. We want to have
    access to theirs, and we'll help them know what our standards
    are and we'll help them know how to meet them. But this is a
    very important step in our relationship with China as well as
    other countries that we will negotiate subsequent agreements
    with.
        Senator Enzi. You mentioned the high risk products. Some of
    the items in the food protection plan would focus on those
    higher risk products. Our food supply is very diverse. How do
    you propose to determine the relative risk?
        Secretary Leavitt. Well there are certain things that are
    perishable, for example. Food inspectors will tell you these
    are always things they look at. But as you talk to inspectors
    at the borders and as you talk to those people who are involved
    they'll tell you there's a whole myriad of things they look at
    to determine who's a risk.
        For example, one wouldn't necessarily think about an
    importer who routinely does not keep the rules. They view that
    person to be a high risk and they want to focus more attention
    on them. And potentially need to spend less of their time on
    people who always keep the rules and in whom they have
    confidence because of their own experience and because they
    have chosen to have their products and their processes
    certified. So they'd like to focus more of their attention on
    people who are historically producing problems and less of
    their attention on people who always keep the rules.
        Senator Enzi. Thank you.
        We all agree that the food and import safety are critical
    issues and the Chairman has raised the comment about the
    resources that have been needed to carry out the plans and I'm
    sure all of us want to work with you and your Department to
    make changes to the food safety system, but no one can expect a
    blank check. So we need to figure out what this is going to
    cost so we can set priorities and get started on fixing the
    problems. What can you tell me about the kind of resources that
    will be needed?
        Secretary Leavitt. Well for the first time we have a master
    plan that lays out in the future what we need to do in order to
    accomplish a 21st century system. We now need to take the 2009,
    2010, 2011, 2012, and 2013 budget and apply it to that master
    plan and invest every year. Now last year the Administration
    proposed more money in each of those categories. We'll
    undoubtedly do the same in 2009 and we now need to then apply
    those appropriations to this plan and the authorities that we
    need Congress to provide us to make this plan work and then
    drive forward.
        Frankly, the advisory panel that the Senator has referenced
    reached many of the same conclusions that we did in our very
    comprehensive look at this system. This report clearly
    manifests that more resources will be necessary. We did not
    attempt to substitute this effort for the regular budget
    process, but it makes very clear that additional sources will
    be necessary to make this work.
        Senator Enzi. Well, I thank you for the courage it took to
    put a plan in writing. We've had a Government Performance and
    Results Act in place for the Federal Government for I think
    about 15 years and this is the sort of thing that we're hoping
    will happen. Where people take a comprehensive view of what
    they are doing as well as any outside groups that might be
    taking a look at it and figure out what needs to be done. And I
    know that that takes a lot of courage and I thank you for it.
        The Chairman. Thank you very much.
        Senator Murkowski.

                         Statement of Senator Murkowski

        Senator Murkowski. Thank you, Mr. Chairman and thank you,
    Secretary Leavitt.
        I too, appreciate the efforts that have gone into this.
    When you think about things that can rattle a family, rattle a
    community, when the food that you have purchased at a grocery
    store and brought home to feed your family makes them ill, it
    is the most invasive, frightening thing that can happen to a
    family. I shouldn't say most. It is a very invasive thing. It
    is a very frightening thing that happens and I think people
    look to the government and say, ``What are you doing about it?
    What have you done to make sure that my family is safe?''
        I want to ask you about the request in the plan for the
    recall. The mandatory recall authority would be used only when
    the current voluntary recall process fails to promptly remove
    foods that present a threat of serious harm to humans or
    animals. Tell me what that really means in application. If
    you're a grocery store and selling spinach and somebody's
    gotten sick, you're going to pull that off because you want
    people, your customers, to keep coming back.
        What has to happen before there is a step in and there's a
    mandatory recall?
        Secretary Leavitt. Senator, I'm going to confess to you
    that it was a surprise to me to find out that the FDA didn't
    have that authority. Now I assumed they did. This goes back a
    couple of years when I discovered this. Why? Because there's no
    indication that it's ever been a serious problem up to this
    point.
        When I talked to the FDA people about how it works, they
    tell me that they say to the manufacturer or the processor,
    ``we think your food is unsafe and we're prepared to make
    public notice that your food is unsafe and recommend that
    people not buy it.'' And people routinely then recall their
    product. There may be circumstances where they refuse to do
    that.
        Senator Murkowski. Have we had any who just refuse to take
    it off?
        Secretary Leavitt. I'll ask David Acheson to answer that
    since he's involved every day in it.
        Mr. Acheson. Yes, we've had several. In the last few years
    it's been two or three issues particularly in the pet food
    industry where companies have absolutely refused and we've had
    to use the strategy that the Secretary's pointed out of
    alerting the public through the media.
        Senator Murkowski. Huh. I guess I assumed that there was
    some authority in place as well.
        Let me ask a question that is more local. We've had some
    situations where there's been seafood, tainted seafood, that's
    come from China and probably from other countries as well. And
    for a market like the Alaska market where we rely on the
    reputation of a good and a safe seafood market when we have the
    news come out that this fish is tainted. Stay away from it.
        Oftentimes the distinction may not be made as to where it's
    coming from. And then the consumer just says, ``Well, the
    safest thing to do is stay away from all fish including the
    domestic product that we worked hard to build the reputation
    for.'' How can we do a better job of making sure the consumer
    is appropriately alerted while at the same time we don't hamper
    or lose ground in promoting our own domestic products where we
    know we've got a level of safety?
        Secretary Leavitt. I'm going to ask David to comment on
    this. But you referenced something that I think is an important
    thing to acknowledge. Earlier we had some conversation about
    lettuce. If there's one incident regarding lettuce then people
    assume all lettuce is tainted and they quit eating it. If they
    have a situation with fish then they assume fish is not good
    and they quit eating fish. And that's a serious threat.
        And frankly it's a big problem to those particular
    industries. And for that reason those industries have begun to
    say, ``We need to have standards that assure that everyone is
    maintaining quality and building it into their product because
    if there isn't, we all suffer.''
        So in the case of lettuce, for example, the produce growers
    got together and the processors and said, ``let's develop some
    standards.'' They then came to the FDA and said, ``here are
    standards that we think are extraordinarily high and would
    protect us, as an industry, by making certain that a few bad
    actors don't spoil the market for everyone.'' And FDA has now
    begun the process of incorporating those standards. We think
    there are other areas where that could and should occur.
        For example in fish where a standard can be developed in
    cooperation with the industry who very much wants what you've
    suggested not to happen. And then use regulatory authority to
    incorporate that process using certification to say once we
    have a standard let's get people we trust to make certain that
    every single processor is meeting that standard. And if they're
    not, we're going to watch them more closely than those that do.
        David, do you want to comment on that?
        Mr. Acheson. I think one of the key elements that you're
    getting at is the importance of communication.
        Senator Murkowski. Yes.
        Mr. Acheson. And making sure that consumers really
    understand what's implicated in a food safety situation and get
    that information to them quickly. And it's not just consumers.
    We need to apply that down to the stores at the local retail
    level. So if there is a recall product it's removed
    expeditiously.
        The corollary of that is that following a recall, as with
    spinach, is to let consumers know that the product is back on
    the market and that it's safe to consume again. So, again it
    really boils down to communication and how to improve on that.
    And a part of the food protection plan is focused on
    communication around the response element.
        Senator Murkowski. Communication by way of advertising?
        Mr. Acheson. By all means. I mean I think part of this
    strategy that we'll use at FDA is to use a new risk
    communications advisory committee that we've established and
    really address what are all the modes by which we can
    communicate with people: media, TV, Internet. And as the
    Secretary pointed out part of that communication is in a recall
    situation of an individual store informing a consumer that the
    product that they may have purchased is a recalled item.
        So there's many, many modes of communication that we need
    to look at because it's not a single one that's going to work.
        Senator Murkowski. Thank you Mr. Chair.
        The Chairman. Thank you very much.
        Senator Murray.

                          Statement of Senator Murray

        Senator Murray. Mr. Chairman, thank you so much for having
    this hearing today. I heard your opening statement. I've got
    several meetings going on but I wanted to come back to ask a
    few questions.
        I agree this is just absolutely a critical issue, a very
    difficult issue. I came into Congress in 1992. And before I
    even got my nameplate we had the E. coli issue with Jack in the
    Box and I had three young kids in my State who lost their lives
    as a result of that. And I know personally how important it is
    that we assure our consumers, our families everywhere, that the
    food they buy is safe. And we have a challenge doing that in
    this country. And we have to continue to take steps forward.
        It's fun to bash government. It's everybody's game, but the
    fact is that government is who regulates food safety and it's
    our agencies who oversee this and the consumers depend on us
    and we've got to be doing the right thing. So I really, truly
    appreciate your having this hearing.
        Secretary Leavitt, thank you for being here today and thank
    you to all of our panelists.
        Secretary Leavitt, I've looked at the food safety plans
    that the FDA has put forward and they contain some
    recommendations for new legislative authorities by the FDA,
    such as the ability to mandate food recalls. I think some of
    those are positive steps, but I'm concerned that the plan
    doesn't go far enough to ensure the public safety because a lot
    of the recommendations involve voluntary approaches. I wanted
    to ask you why you focused on voluntary approaches instead of
    required compliance measures?
        Secretary Leavitt. Our desire was to focus the energy of
    whatever resources we have in the areas where there is most
    risk and to be able to expand that by rewarding people who go
    to the point of adopting standards and certifying them to
    expand our reach. If we have more eyes we're able to, in
    essence, reach more. We think we can get people to voluntarily
    do that because of the advantages it gives them for example, on
    imports and being able to get their products into the country
    safely.
        Senator Murray. What if somebody doesn't do it?
        Secretary Leavitt. Then we need authority to be able to
    police that.
        Senator Murray. Which means you need additional resources
    to be able----
        Secretary Leavitt. Which means we need to be able to have
    the authorities to use the resources that we have to enforce
    it.
        Senator Murray. Well, authority is one thing and resources
    another. If you don't have enough inspectors and you don't have
    enough ability to go out there and make sure that people are
    voluntarily complying then, all the voluntary measures in the
    world don't work. I mean we've certainly seen that over and
    over again.
        I know Senator Enzi asked about the resources as well, but
    I know, we all know, we're in tight budget times, but I think
    safety of our food is a really critical issue. And I wanted to
    ask you what we can expect to see from the Administration in
    the fiscal year 2009 budget request for this?
        Secretary Leavitt. We'll be requesting more money to
    support this plan, as we did in 2008. We're in the process of
    developing that budget along with the Office of Management and
    Budget. So, I'm not in the position to say the precise amount,
    but I can tell you I have requested substantial additional
    budget for the FDA and for the other parts of HHS that are
    relevant to this matter, as I know other departments have.
        I think it's again important to point out that when we
    looked at the totality of the system there were 12 different
    departments and agencies that were involved. This can't be just
    the FDA budget. It's got to be the entire budget based on a
    plan that coordinates all of it.
        It also needs to coordinate what goes on in the private
    sector. Now, retailers today are saying to their producers,
    ``if you want space on my shelf, you need to show me, to the
    point that I have no question, about the quality and safety of
    your goods because I'm putting my reputation on your good when
    I put it on my shelf.'' And some of the most aggressive
    inspection, some of the most aggressive oversight on food and
    product safety is coming from those whose brand depend on it.
        Senator Murray. Ok, I understand that. But did--can I go
    back just a second?
        Then I heard you say that we will see an increase in the
    budget, when it comes from the President, to cover these
    agencies.
        Secretary Leavitt. Well what I'm able to tell you is that I
    have proposed substantial additional resources from the HHS
    level. History tells me I usually don't get as much as I ask
    for, but I expect that there will be more in this budget.
        Senator Murray. Thank you. Thank you very much, Mr.
    Chairman.
        The Chairman. Thank you very much.
        Senator Roberts.

                          Statement of Senator Roberts

        Senator Roberts. Thank you Mr. Chairman. First I'd like to
    associate myself with the remarks by my friend and colleague
    from Colorado, Senator Allard, who indicated that despite all
    of the problems we have and the challenges we have, and as the
    Secretary has indicated, the current system is not adequate for
    the future, that we still have the safest food supply in the
    history of the world and by the way, at the lowest cost.
        I do not think that we have a full blown crisis in regards
    to public confidence of our food supply. I hope that's not the
    case. Having said that, I can certainly appreciate it because I
    can remember very well going to the State of Washington at a
    Trade Round between what I'll affectionately call the Tear Gas
    Round. That was some years ago in the State of Washington, in
    Seattle and that was just following the tragedy in regards to
    Jack in the Box and that 100 percent loss for those families
    involved.
        I must tell you as Chairman of the House Agriculture
    committee at that particular time we conducted an inquiry, not
    an investigation into that, and found out it was a good idea to
    cook the meat. And from that time on I think most Americans
    decided that medium and well would be better served than rare.
        I ordered a cheeseburger by the way. I would tell my
    colleague, the Senator from Washington, the distinguished
    Senator from Washington and I couldn't get a cheeseburger,
    because of that situation and the turmoil and the trauma that
    all of that caused. I finally signed a liability statement so
    that I could get a cheeseburger. Now that's carrying this thing
    entirely too far. By the way it tasted like shoe leather. I
    didn't ever do that again.
        I can remember too that, you know, pointing out the
    problem. Congressman Dooley will be part of a panel coming up.
    And I hope everybody pays attention to Cal because he does have
    a tremendous experience in the Congress and in the private
    sector in regards to what he has to say on some positive
    measures that the private sector will implement or is trying to
    implement in regards to food safety.
        But we have a parts per trillion technology now, Mr.
    Chairman. It's very difficult. There's a little bit of
    something on everything. Parts per trillion.
        And I can remember a case, again back in the House, and I
    apologize for going back to those days when I was somebody. But
    at any rate, this was a situation on an additive in regards to
    peanuts and there was an effort, an amendment on the floor of
    the House to terminate the use of that additive. And we figured
    out finally as we extrapolated what happened in regards to the
    test to determine whether it was safety or not that a person
    would have to eat 600 pounds of peanuts a day for that to
    become a problem. There were some people in the House at that
    time that I recommended eat 600 pounds of peanuts a day, but we
    didn't get into any names.
        And I'm not trying to be glib. I'm not trying to be
    sarcastic. I'm just trying to point out that we do have a parts
    per trillion technology that enables you to do a tremendous job
    in terms of enforcement, if in fact, you can go beyond what we
    have now and have the resources to do it and I applaud your
    efforts.
        What I would like to ask is this. As we review this issue
    it seems there may be some things we can look to that may serve
    as a model. That we might consider. And my druthers are this,
    or my prejudice is this, because I think it would work.
        It seems part of the solution would lie with getting the
    entire food supply chain, the entire food supply chain, to act
    on their own to the benefit of food safety. For the entire food
    chain to be the owners of prevention-based interventions built
    on some form of accountability, primarily based on traceability
    and then your enforcement capability. All this accomplished
    under some form of government certification and oversight than
    in the worst case scenario you can act.
        And it's my understanding that today there are prevention-
    based interventions. And I'm really talking to the agriculture
    side, but it can apply to the FDA as well, that exceed minimum
    government requirements that exist today which can accomplish a
    safer food supply. But there's very little incentive for them
    to be implemented by our current system.
        How can we incentivize them other than being punitive for
    them to do that? Obviously it would be in their best interest.
    And I would imagine that Mr. Dooley, who is sitting patiently
    here with his arms crossed, would speak to that. But could you
    respond to that in regards to incentivizing the private food
    system to go beyond the government standard in their own best
    interest?
        Secretary Leavitt. Dave, would you like to comment on that?
        Mr. Acheson. Yes, happy to. I think probably the easiest
    example to give to you is one in relation to imports. As the
    Secretary has pointed out, the current system is based on
    inspection at the port of entry. And the vision that we're
    moving forward is this whole part of life cycle process.
        If, in that process, we understand the preventive controls
    that work in foreign manufacturers and we know through our risk
    assessments that they're implementing those preventive
    controls. Then I think a significant incentive would be that
    those products would be less likely to be inspected at the port
    of entry because we know already that they're being
    manufactured under a system using preventive controls. If
    they're going beyond what we do, so much the better, but at
    least to the minimum of what we expect for FDA.
        So I think in that context through working with our
    stakeholders, working with foreign governments, the private
    sector, we can provide information about what are those
    preventive controls. Where are the risks? What are the
    concerns? And essentially help drive the system. Pushing the
    resources where we need to, to the areas of greatest risk and
    thereby providing incentives to industry to adopt those
    preventive measures.
        Senator Roberts. Mr. Chairman, my time is up. I didn't know
    if the Secretary wanted to add anything or not.
        Secretary Leavitt. Well, I would simply say that if we
    assume that government will own the entire system, it will not
    be as good a system as one government organizes that
    incorporates all of the aspects of government, both State,
    local and the private sector. And the remarkable incentives
    that are there for those who desire to have products that are
    delivered to consumers on a safe and effective basis.
        I mentioned, I think you were here, but perhaps not, the
    circumstance with lettuce a couple of years ago where the
    lettuce producers said, ``anytime a bad actor performs in a way
    that taints us all, we all lose.'' And so let's get together
    and harness our capacity to hold everyone to a standard. And if
    we do, the market improves. And we can then use government as a
    means to discipline those who do not meet that standard in
    addition to what the market does, then we'll get to the point
    that we're building quality into the product as opposed to
    standing at the border hoping to catch a few that try to cheat.
        Senator Roberts. Mr. Chairman, I don't want to open up an
    old wound, but I also remember the case of Alar and apples. It
    cost the apple industry $600 million one year. We had people in
    a school lunch program throwing away apples. It wasn't Mom and
    apple pie anymore.
        It was quite a few years ago and that was a shelf
    preserver, but the consumer did not want to buy the apple that
    did not have the shelf preserver because it didn't look that
    good. Now there's some question as to whether Alar was proper
    or not, but the industry suffered $600 million. And at that
    particular time they would have done anything, anything, in
    terms of public information through the FDA, through
    themselves, but they just didn't have the wherewithal to do it.
        And so we really went through a very difficult time which
    is why I think it is so important that you are having this
    hearing Mr. Chairman and why you have asked for additional
    funding and knowing that we have to go beyond what we have now.
    Thank you, sir.
        The Chairman. Thank you.
        Senator Allard.
        Senator Allard. Thank you Mr. Chairman. And Mr. Secretary,
    you know as Governor, I think that your health department and
    the various county departments are extensions of State
    government and I think most States organize like this because
    they have uniform rules and regulations. They put out to the
    States and the States adopt them, have the authority to close
    down a business if they wanted to do it.
        And so we get to the issue well, is it more appropriate at
    the Federal level? Is it more appropriate at the local level as
    far as enforcement is concerned? And having been in an
    enforcement process myself, I mean, if you go in and you close
    down a business, they're out of business if it's a grocery
    store.
        And so what happens, you know if you saw a bad can on the
    shelf that was distended indicating there was gas production
    then you took it off immediately. And the owner usually did
    that because they understood that you had the power to close
    down their business if they didn't because it was a human
    health issue. I'm talking about human health. So it's a human
    health issue.
        So if you look at this I think you will find that there's
    adequate enforcement and a lot of enforcement that happens
    through the State Health Departments as well as the local
    health departments work as an extension of the State health. At
    least that's what happens in my State, in Colorado. And I think
    that happens in most States.
        From my personal experience, if we have a problem at a
    local level with a retailer, he's going to respond. Not only
    for public relations purposes, because he realizes that the
    local health department inspector has pretty good control over
    getting something off the shelf that's going to be an immediate
    public health problem. And as soon as it gets recognized, if
    necessary, you go to the judge, and you can go to the judge and
    get a quick court order, locally and get it done.
        My question is that with these various issues that have
    been brought up in the last year and particularly the spinach
    and the salmonella in the peanut butter and the E. coli in the
    spinach. With the recommendations that you're now dealing with
    that's come out of the working group, how would you handle this
    situation differently in the last year? Would there have been a
    change in the way you've managed those situations which you're
    talking about with new recommendations from the working group
    and yourself and what we now do? Is there going to be any
    change there?
        Secretary Leavitt. I will ask David to respond from a food
    regulator standpoint. But let me make this point as a
    policymaker. Consumers will punish harshly and rapidly those
    that don't produce safe and quality products. There are times
    when government is necessary to go further and to use different
    authorities to do that.
        I think you've asked a very important question about the
    circumstances that occurred recently. I think it's important to
    acknowledge we cannot eliminate all risk from society. There
    will always be circumstances that occur where something goes
    wrong and something that isn't as safe as our expectations, as
    we aspire it to be. That's why we have this system--to catch
    those moments and to make certain that they do not become
    public health problems.
        David.
        Mr. Acheson. I think one point that probably won't change a
    great deal is our ability to respond. When we have an outbreak
    in spinach we get on it quickly and we respond. And I'd like to
    find ways to improve that but substantially that system is
    working.
        What will change is to try to prevent it ever happening in
    the first place. What we've got to do is maintain that rapid
    response when we need it. But really figure out how to prevent
    the problem from ever happening in the first place through
    targeted risk-based prevention and intervention strategies.
        Senator Allard. I do agree with Secretary Leavitt's
    comments. You're not going to have it completely risk-free. We
    do things in public health that reduce the risk. For example in
    handling foods on a butcher table we go out and do swabs on the
    butcher table and if the bacteria count is too high it
    indicates there's improper sanitation. If it's at a low it
    indicates that they're using proper sanitation, but you never
    completely get rid of the bacteria.
        But it's safe bacteria that we test for. It's E. coli, as a
    matter of fact, that we test for. It's not the hazardous E.
    coli that causes human disease, but we look for the safe. And
    so, you know if the E. coli count is too high it indicates
    there's improper sanitation, but there's always that risk that
    some move forward.
        So there's also an important educational element here that
    the food preparer needs to know that if you're dealing with
    salmonella you don't take eggs and mayonnaise and put them in a
    potato sack and let it sit in the sun. You know, I don't care
    how rigorous your inspection is, that's going to be a problem.
    Same thing with raw meats, I mean, if you've got raw hamburger
    that's ground and you don't cook it properly you run a high
    risk of eating the pathogenic, the one that causes disease, E.
    coli. If you cook it thoroughly the risk isn't there.
        So, there's a big educational effort there and in the
    working group's recommendations did they say anything about
    educating food preparers so that they would be more aware of
    that? I don't think people are as aware of that as at some
    other past time in our history. It seems like that is one area
    where we're falling down is the educational side.
        Thank you, Mr. Chairman.
        The Chairman. Thank you Mr. Secretary. I just want to
    mention one last point here with regard to the FDA Science
    Advisory Board and I'll submit some other questions.
        The Chairman. This is what they pointed out with regard to
    resources. In the recent Executive order announcing the
    interagency working group on import safety, President Bush
    stated that the current system must be fixed ``within available
    resources.''
        Now this is what they conclude. This is the FDA Science
    Advisory Board. ``We can state unequivocally that the system
    cannot be fixed within available resources.'' That's what they
    say. That's the Advisory committee.
        They've just made the finding that the system is broken.
    We're talking about what's going to happen off in the future
    and they say, ``we can state unequivocally that the system
    cannot be fixed within available resources. Infrastructure
    improvements to enhance existing laboratories, equipment and
    personnel will require additional $10 million for CFSAN, $40
    million for ORA. These estimates do not include funds required
    to modernize the assessment of animal-derived products'' and
    all the rest.
        So, this is the Science Advisory Board talking about the
    existing system here. We're concerned. We've heard your
    testimony about the future, what's necessary for that. They're
    talking about today. What is the here and now that is
    threatening the agency's ability to provide safety.
        Now what are you going to do about it? The American people
    are watching. You're the man. They want to know whether you
    have a sense of urgency to make sure there's going to be
    adequate resources. Not this proposal here. It isn't dealing
    with FDA science and technology. Your proposal does not deal
    with it.
        So we want to know what you're going to do about their
    conclusions that the agency is in trouble and needs help. And
    you're the man. This is the time. What's your response? Are you
    going to get them additional help and assistance so that they
    can do the job to protect the American food supply?
        Secretary Leavitt. Senator, I am the man and here is the
    plan.
        [Laughter.]
        It is a road map for continual improvement starting today.
    We're implementing parts of this now. You referenced the
    Executive order that indicated that this would need to be
    implemented within available resources.
        Now the working group went back to the President when we
    made our report and said, ``we do not find that possible.'' And
    the report itself says this will require additional resources.
    And I believe you will see additional resources in the
    President's budget and in future Presidents' budget to
    implement this very comprehensive plan.
        The Chairman. Ok. Thank you very much.
        Secretary Leavitt. Thank you.
        The Chairman. I appreciate it. We'll move on to our next
    panel.
        Our witnesses are Michael Taylor, a former USDA and FDA
    food safety official now at George Washington University.
        Paul Young of the Waters Corporation, a Massachusetts
    Company. Dr. Young was a food safety inspector in Great
    Britain, with expertise on the EU and Japan.
        Cal Dooley, a former Congressman from California, family
    farmer, is the president of the Grocery Manufacturers
    Association.
        Caroline Smith DeWaal. Is that pronounced correctly?
        Ms. DeWaal. Yes.
        The Chairman. Thank you. Is the Director of Food Safety,
    the Center for Science in the Public Interest. She is a lawyer
    and has laryngitis today. So Mr. Plunkett will deliver her
    testimony, but she's here and going to help us with some
    questions.
        And Joe Corby, the Director of Food Safety, New York State,
    37 years experience in food safety.
        Senator Enzi. Mr. Chairman.
        The Chairman. Yes?
        Senator Enzi. While they're getting seated there I'd also
    ask unanimous consent to include a statement from an outside
    group, the American Frozen Food Institute.
        The Chairman. It will be so included.
        Senator Enzi. Thank you.
        [The information previously referred to follows:]
        Prepared Statement of the American Frozen Food Institute (AFFI)
        Chairman Kennedy, Ranking Member Enzi and members of the committee,
    thank you for the opportunity to submit this statement for the record.
    We appreciate your commitment to food safety and commend the committee
    for holding this important hearing.
        The American Frozen Food Institute (AFFI) is the national trade
    association that promotes and represents the interests of all segments
    of the frozen food industry. AFFI fosters industry development and
    growth, advocates on behalf of the industry before legislative and
    regulatory entities, and provides additional value-added services for
    its members and for the benefit of consumers. AFFI members manufacture
    and distribute frozen foods throughout the United States and globally
    and are committed to ensuring that these products are produced in
    accordance with strict standards of safety and quality.
                   u.s. food and drug administration funding
        Americans spend more than $1 trillion on food--nearly half of it in
    restaurants, schools and other places outside the home. Consumers have
    a reasonable expectation that the food products they buy are safe.
    While much is being done to ensure the safety of these products,
    safeguards must be continually updated to meet the changing demands of
    a global economy.
        The combined efforts of the food industry and government agencies
    are credited with making the U.S. food supply among the safest in the
    world. Recent food safety incidents, however, have spurred debate about
    whether our regulatory agencies have adequate resources to do their
    jobs as effectively as possible, and whether the current Federal food
    safety laws have kept pace with the significant advancements in food
    production, processing and trade.
        While it is impossible to eliminate all potential food safety
    risks, we can work smarter to reduce risk. It requires the creation of
    new and innovative ways to protect American consumers and continual
    improvement in managing the safety of our imports, in addition to our
    domestic production. Approximately $2 trillion of imported products
    entered the U.S. economy last year and expert's project this amount
    will triple by the year 2015. Meanwhile, the major U.S.-food regulatory
    agencies continue operating at budget levels well below amounts needed
    to keep up with the influx of imports.
        Food safety always has been and continues to be a top priority for
    AFFI and its more than 500 member companies. This year, the Institute
    joined the Coalition for a Stronger FDA in its efforts to build public
    support for increased funding for the U.S. Food and Drug Administration
    (FDA).
        The Coalition for a Stronger FDA is comprised of consumer and
    public health advocates, food and medical industry representatives, and
    more than 50 patient groups working to ensure FDA remains well-
    positioned to protect Americans. Funding for FDA is critical,
    especially because the agency will be called on to address an
    increasing array of domestic and international issues in the coming
    years--including revolutionary food and medical advancements. The
    Coalition is undertaking a multi-year effort to ensure FDA has
    sufficient resources to protect patients and consumers, and to maintain
    and build public confidence and trust in the agency.
        The frozen food industry will continue to work with government
    leaders, as well as others within the business community and the
    general public to ensure government agencies with oversight over food
    safety have the necessary resources to fulfill their responsibilities.
    The work that the dedicated men and women of these agencies,
    particularly FDA, do every day directly affects the lives of every
    American--from public health to nutrition assistance, both at home and
    abroad. Failure to adequately invest in these programs will have
    serious long-term consequences for our country and its consumers.
        Although the U.S. food industry has a tremendous track record of
    supplying the world with safe, high quality food, we certainly
    recognize the necessary and complementary role that FDA and other
    regulatory agencies play. These entities ensure public health through
    the establishment of food safety standards and by carrying out
    necessary testing, inspections and scientific research.
        In the wake of recent, highly publicized food safety concerns,
    significant budget increases will allow agencies such as FDA to help
    reassure consumers, speed innovation in food safety and medical
    technology, and ensure the U.S. remains competitive in foreign markets.
    A $115 million increase in the food budget, for example, would allow
    FDA to hire more food inspectors, speed approvals for safe new food
    technologies and products, and provide leadership in protecting the
    food supply from intentional threats.
        The proposed increase in funding that AFFI and the Coalition for a
    Stronger FDA seek will assist FDA in developing new strategies and
    continuing important work in the areas of regulatory enforcement,
    monitoring and inspection, international harmonization, science-based
    oversight, foreign food safety assessments and technical assistance,
    and trade. These efforts are intended to enable the agency to remain an
    effective force in resolving international issues bearing on the
    safety, quality, and labeling of foods and other products.
        This budget increase also will allow FDA to hire the next
    generation of highly qualified scientists and other career agency
    personnel who will be the future recipients of critical institutional
    knowledge on a wide range of food safety issues. Without these funds,
    the agency will face a critical shortage of expertise in the future.
                              food safety systems
        Although the food industry has developed and implemented
    sophisticated food safety assurance methods, Federal and State
    regulatory officials have traditionally depended on spot-checks of
    conditions and random sampling of final products to monitor compliance
    with applicable regulations. This approach has tended to be reactive
    rather than preventive with limited ability to address the many
    challenges with which an industry as dynamic as the food industry is
    increasingly faced.
        Among the most important challenges in recent years has been the
    increasing number of new food pathogens. There was also increasing
    public health concern about chemical contamination of food products.
    Other key challenges confronting the industry and regulatory agencies
    over the years has been the increasing size of the food industry,
    diversity of products and processes, amount of domestic food
    manufactured, and the number and kinds of foods imported. At the time,
    FDA and State and local agencies had similar levels of resources to
    ensure food safety.
        The food industry has effectively and, for the most part,
    voluntarily employed the Hazard Analysis and Critical Control Point
    (HACCP) system to identify and address potential hazards in food
    processing. But HACCP is a dynamic system tailored to the unique
    conditions in each individual processing facility. A foundation of
    complementary preventive control programs is necessary for HACCP to be
    effective. For example, the Current Good Manufacturing Practices
    (CGMPs) are fundamental building blocks that can be applied generally
    to all food facilities. By strengthening the preventive controls, food
    safety can also be enhanced.
        AFFI has been working with FDA and a coalition of more than 60 food
    companies and trade associations to modernize CGMPs regulations for
    foods. These building blocks include employee training, allergen
    management, environmental monitoring, sanitation practices, and other
    critical tools.
        For more than 25 years, CGMPs have formed the basis for safety
    assurance programs in food manufacturing facilities, and they have been
    very effective. Given today's food safety concerns and the development
    of new technologies for addressing such concerns, AFFI supports FDA's
    efforts to modernize food CGMPs and ensure their application in all
    processing facilities. In so doing, we have urged the agency to build
    on and enhance the existing regulations, which should continue to serve
    as foundational, prerequisite conditions for producing safe food
    products.
                                   conclusion
        In today's global economy, continued and enhanced cooperation
    between industry and government is critical to ensure the safety of the
    U.S. food supply. The regulatory agencies, especially FDA, need
    adequate resources now, and in the future, to carry out their mission
    and mount the challenges of a continually growing global marketplace.
    Working with FDA, the food industry needs to employ preventive control
    programs that take advantage of modern technology.
        Once again, thank you for the opportunity to submit this statement
    for the record. We look forward to working with members of the
    committee on this and other issues of relevance to the frozen food
    industry.

        The Chairman. OK. Mr. Taylor.

     STATEMENT OF MICHAEL R. TAYLOR, RESEARCH PROFESSOR OF HEALTH
       POLICY, THE GEORGE WASHINGTON UNIVERSITY, WASHINGTON, DC.

        Mr. Taylor. Mr. Chairman, Senator Enzi and members of the
    committee I do appreciate greatly this opportunity to testify
    today on strategies to improve food safety and on the FDA's
    Food Protection Plan.
        Earlier this year the Government Accountability Office
    declared the Federal Government's Food Safety Program at high
    risk of failure due to its outdated laws, fragmented structure
    and inefficient use of resources. This conclusion came after a
    decade of recommendations from GAO and the National Academy of
    Sciences to modernize the system, legislatively and
    organizationally so that it can be effective in preventing food
    safety problems instead of simply reacting to problems after
    the fact.
        The consequences of not acting on the GAO and NAS
    recommendations are clear. We've heard about them today. They
    include an unacceptably high burden of preventable foodborne
    illness, a chronic inability to keep up with the food safety
    challenges of today's global food system and declining public
    confidence in the safety of the American food supplies.
        So Mr. Chairman, it is time, at last, to begin the reform
    process. It won't be easy. I can assure you of that. We're
    talking about a food safety system that has evolved over many
    decades without a coherent plan or strategy and that now
    includes some 20 components of FDA, USDA, EPA and CDC, 3,000
    State and local agencies and a myriad of obsolete laws.
        The needed modernization of this complex system will take
    time to design and implement and should be pursued with due
    deliberation and care. But it must be pursued starting now. And
    I believe the right starting point is the Food and Drug
    Administration.
        Among all of our agencies involved in food safety, FDA has
    long been looked to as the natural focal point for food safety
    leadership in the United States and internationally. It
    oversees 80 percent of the U.S. food supply including an even
    greater share of imported food and is the steward of a long
    tradition of effective, science-based regulation to protect
    public health. As we now know however, FDA's ability to provide
    the needed food safety leadership is badly constrained, not
    only by obsolete statues that focus more on reaction than
    prevention, but also by plainly inadequate resources and an
    internally fragmented and ineffectual organizational structure.
    I believe all of these problems must be addressed for FDA to be
    successful in an increasingly complex globalized food system.
        Now as we embark on a comprehensive modernization process
    we need to get the basic policy principles right. And I think
    you will find good agreement among experts on the following
    five principles around which resources and institutions should
    be mobilized.
        First, you must treat food safety as a farm-to-table
    systemwide problem. This simply recognizes that hazards can be
    created and minimized at many points across the system and we
    should take advantage of all opportunities to reduce risk.
        Second, we must make prevention of food safety problems the
    central focus of the system, as we've been hearing today
    because this is the only way. Preventing problems is the only
    way to protect public health and maintain public confidence.
        Third and very critically, we have to recognize again as
    we've heard here today that the primary duty for prevention
    falls on the food industry. The food industry, after all, not
    government produces food and only the industry can make it
    safe.
        Equally important however, we must focus, this is the
    fourth principle. We must focus FDA's program on setting and
    enforcing standards that make the food industry accountable for
    prevention. I believe ensuring accountability for prevention by
    setting and enforcing standards is the unique and most
    essential government role on food safety.
        Fifth and finally, we do have to strengthen FDA's mandate
    for providing national leadership on food safety. And we've got
    to bolster the agency's tools for managing the science and
    risk-based regulatory program and of course the FDA Science
    Board report certainly underscores this need to bolster FDA's
    science tools. This includes the ability to exercise--national
    leadership includes working with State and local governments
    and the industry to build a modern, nationally integrated
    system that harnesses the best science and that makes good use
    of all of its resources.
        Mr. Chairman I'm glad to say that FDA's food protection
    plan embraces many of these principles at least conceptually,
    including the need for a farm-to-table approach, focus on
    prevention and industry responsibility for prevention and it
    contains many specific ideas that are worthy of adoption. I do
    applaud the Secretary and the FDA staff for the effort and
    thought that I know went into developing the plan.
        The plan falls critically short however on implementation
    of what I consider the most fundamental policy change required
    to make the FDA's program effective which is as I've indicated,
    establishing clear and comprehensive industry accountability
    for prevention and doing this with respect to both domestic and
    imported food. Rather than establish that accountability the
    FDA plan relies almost entirely on voluntary approaches to
    implementing preventive controls in the food industry. In fact
    under the plan as the Chairman indicated in his opening
    remarks, FDA would be able to require preventive controls only
    if it could establish through rulemaking, that a particular
    food has been associated with repeated, serious, adverse health
    consequences or death.
        This standard is actually more restrictive of FDA's ability
    to act preventively than the authority FDA has been able to use
    under current law to require preventive controls for seafood
    and juice. Moreover, requiring FDA to prove that such serious
    harm has already occurred treats preventive process control as
    a tool for reacting to problems rather than systematically and
    comprehensively building prevention into the system.
        Mr. Chairman, we should not be afraid to regulate in the
    name of food safety. We know that preventive process control is
    the standard of care that many leading and responsible
    companies have developed themselves and are already observing.
    It should be the standard of care for everyone in the business
    of producing and marketing food to American consumers. In my
    view we would neither accomplish our public health goal nor
    have a system that is credible in the eyes of the public if we
    make the basic commonsense preventive control optional and
    leave FDA in the role of encouraging progress rather than being
    a credible source of standards and accountability for doing
    food safety right.
        Of course we have to be smart about regulation. Old
    fashioned command and control regulation can impose unnecessary
    cost and stifle innovation. The food industry itself has
    historically been the source of much valuable innovation to
    improve food safety. Regulations should foster that innovation,
    not stifle it.
        To that end modern effective regulation is clear in setting
    performance standards for companies and flexible in how
    companies can achieve the standard. It's not a one-size-fits-
    all approach and we should work to assist small businesses. But
    the public rightfully looks to government to set and enforce
    standards to achieve goals like food safety that people can't
    achieve solely on their own.
        In sum Mr. Chairman, I hope this committee and Congress
    will move forward in concert with the many stakeholders in the
    food safety system to modernize FDA's food safety authorities
    in accord with the five principles I've outlined today. I hope
    Congress will work also to solve the serious resource and
    organizational problems that are obstacles to FDA's success.
    And we've heard about that today and I won't elaborate. But the
    resources of FDA's food program have eroded down to a level
    where they really are unable to take leadership and take
    initiative.
        Mr. Chairman we need to get FDA's food safety policies
    right and we need to then back them up with the resources and
    organizational structure to do the job. Thank you again for
    this opportunity to testify. I look forward to questions.
        [The prepared statement of Mr. Taylor follows:]
                   Prepared Statement of Michael R. Taylor *
        Mr. Chairman, Senator Enzi, members of the committee, I appreciate
    this opportunity to testify on strategies to improve food safety and on
    the Food and Drug Administration's recently issued Food Protection
    Plan.
                                  introduction
        This hearing is timely and important. For over a decade, the
    Government Accountability Office (GAO) and expert committees of the
    National Academy of Sciences (NAS) have been documenting fundamental
    problems in the Nation's food safety system--a system that has evolved
    over many years without a coherent plan or strategy and that now
    includes some 20 components of FDA, USDA, EPA, and CDC, and 3,000 State
    and local agencies.
        Among all these agencies, FDA has long been looked to as the
    natural focal point for food safety leadership in the United States and
    internationally. It oversees 80 percent of the U.S. food supply
    (including an even greater share of imported food) and is the steward
    of a long tradition of effective, science-based regulation to protect
    public health.
        Unfortunately, FDA's current ability to provide food safety
    leadership, or even meet its basic food safety responsibilities, is
    badly constrained by:

         Obsolete statutes that date back to the 1930's and focus
    more on reacting to problems than preventing them;
         Inadequate resources that are dwindling in the face of an
    increasingly complex, global food supply; and an
         Internally fragmented and ineffectual organizational
    structure that makes FDA incapable today of providing effective food
    safety leadership.

        Certainly, FDA could be doing more with its present tools to
    address some of today's pressing food safety problems. I believe,
    however, that FDA will continue to fall short of what the public needs
    and expects from this critical public health institution until Congress
    provides a modern statutory mandate, an adequate and stable resource
    base, and an institutional structure capable of national and
    international leadership on food safety.
        And that is why it is so timely and important for this committee to
    be focusing on how to improve FDA's food safety program. Getting food
    safety right at FDA is essential to the public's health, to the
    confidence people want to have in the food they feed themselves and
    their families, and to the economic success of the food system. This
    committee's leadership will be essential to achieving these outcomes.
        In my testimony today, I will not linger over the litany of what's
    wrong with the FDA program. I will instead focus on what I believe are
    the core policy elements of a successful strategy for improving food
    safety, and I will assess the new FDA Food Protection Plan in light of
    those elements.
        In general, I find that the FDA plan contains many of the policy
    ideas that experts agree are important to ensuring food safety--and
    thus provides a platform on which to build. It falls critically short,
    however, on clearly and properly defining the complementary but
    distinct food safety roles of the food industry and the government. As
    a result, the FDA plan does not include actions and recommendations
    that I think are vital to FDA's success.
        I note also that the administration's plan is silent on FDA's
    resource and organizational problems, but I will focus in this
    testimony on the core policies that should underlie FDA's food safety
    strategy and program.
           core policy elements of a successful food safety strategy
        The following are the five core policy elements that I consider
    essential to a successful FDA food safety strategy.
    1. Treat food safety as a farm-to-table, system-wide problem.
        For most of the 20th century, food safety regulators focused
    largely on basic sanitation in processing plants, chemical contaminants
    in food, and the safety of chemical additives. It was possible then for
    FDA to focus on a relatively narrow set of establishments, commodities,
    and decision processes through which those concerns could be addressed.
    Over the last 20 years, however, the problem of foodborne illness
    caused by microbial pathogens has emerged as a central food safety
    concern and one that requires a broader, ``farm-to-table'' approach to
    ensuring food safety.
        A farm-to-table approach is required due to the simple reality that
    dangerous bacteria and other pathogens can enter the food chain at
    almost any point, from production on the farm through processing,
    retail sale, and final preparation for consumption; they can grow; and
    they can be killed. Thus, whether someone gets sick depends not on any
    one contamination event but on a wide range of events and behaviors
    that occur across the entire farm-to-table food system and that, in
    combination, determine the likelihood dangerous levels of an organism
    will be present at the point of consumption.
        This expanded understanding of food safety makes everyone--from
    farmers to consumers, as well as government food safety agencies--
    actors in the food safety system. It creates the opportunity and need
    for integrated action to minimize food safety risks at points all
    across the farm-to-table system--wherever pathogens can enter the food
    and grow or be reduced. FDA's food safety program must recognize and
    act on this reality, as recommended repeatedly by GAO and NAS.
    2. Make prevention of food safety problems the central focus of the
            system.
        Prevention is the core principle of public health and should be the
    central focus of the food safety system. Prevention of problems is
    certainly what consumers expect of the system, and it's the core
    principle that drives modern approaches to food safety. Most notably,
    HACCP (Hazard Analysis and Critical Control Points) is a system of
    preventive process control that was developed originally by the food
    industry as a method for anticipating and preventing food safety
    hazards in particular food production and processing operations.
        FDA has adopted HACCP as a regulatory requirement for seafood and
    juice, but prevention is not an explicit part of its statutory mandate.
    In fact, FDA's food safety legal authorities are designed primarily for
    reacting to and correcting problems after they occur, not for
    preventing them. In an on-going outbreak of foodborne illness, swift
    reaction and containment measures are important and can reduce the
    number of illnesses associated with that outbreak, but, to protect
    public health and meet public expectations for food safety, preventive
    measures such as HAACP need to be built in to the system so that the
    risk of food safety problems occurring in the first place is minimized
    to the greatest extent reasonably possible.
        FDA currently pursues prevention of this kind only on a selective
    and ad hoc basis. A comprehensive, systematic approach to prevention
    should be a core principle and central focus of the food safety system.
    3. Recognize that the primary duty for prevention falls on the food
            industry.
        This may be the most crucial point to emphasize in getting roles
    and relationships between government and industry right. The
    unavoidable reality is that government does not make food, and
    government cannot make it safe. That's the food industry's job, and
    making food safe--doing everything reasonably possible to prevent food
    safety problems--is the most fundamental duty food producers and
    processors owe to America's consumers.
        Many of our Nation's leading food processors and retailers take
    this duty very seriously, and they make extensive efforts to fulfill
    it. They know food safety doesn't just happen; it's the result of a
    plan. So they impose safety specifications on their suppliers to be
    sure their raw materials and ingredients are safe; they implement HACCP
    and other preventive control measures within their processing plants;
    and they test their finished products to verify that their control
    systems are working. In fact, over the years, much of the food safety
    innovation in the United States has come from companies that take food
    safety seriously and have plans for achieving it.
        The problem is that many of the Nation's 44,000 food manufacturers
    and processors, 114,000 food retailers, and 935,000 restaurants do not
    have effective food safety plans. And, at the farm level, systematic
    planning for prevention of food safety problems is in its relative
    infancy. This must change.
        Any business involved in producing, processing, and marketing food
    must have a plan for making it safe, based on modern preventive
    controls. This does not mean a one-size-fits-all approach. It does not
    mean HACCP per se for every commercial participant in the food system.
    But it does mean that anyone producing food for today's marketplace
    should know how they are going to make it safe and should do that
    consistently, every day.
    4. Focus FDA on setting and enforcing standards that make the food
            industry accountable for prevention.
        While the food industry is inherently responsible for making food
    safe by acting preventively, FDA's job as a public health regulatory
    agency is to set and enforce standards that make the industry publicly
    accountable for prevention, in accordance with a defined standard of
    care. Setting standards for prevention means defining the
    responsibility of food producers, processors and retailers to have and
    implement food safety plans based on modern preventive controls. It
    also means establishing performance standards that define the level of
    protection, or food safety performance, that is to be achieved through
    preventive controls, such as the levels of chemical residues or
    microbial contaminants that are deemed acceptable.
        Standards protect food safety only if companies comply with them,
    and it is FDA's job to ensure compliance through inspection and
    enforcement. For many leading companies, compliance is not an issue: if
    the government sets a food safety standard, they will organize their
    systems to comply. In fact, many will go beyond what the government
    requires in response to the demands of their customers expressed in the
    marketplace. The food industry is, however, highly diverse, with some
    companies lacking the market incentive or an internal culture that
    ensures they meet high food safety standards. That's why government
    standards and government enforcement are needed, and it's why they are
    in the interest of both consumers and those in the industry who take
    their food safety job seriously and do it well.
        Government regulation of food safety is essential, but it has to be
    smart regulation. We have learned that old fashioned ``command and
    control'' regulation - in which the government specifies not only the
    outcome to be achieved but how industry must achieve it--can impose
    unnecessary costs and stifle innovation. Instead, modern regulation is
    clear in setting performance standards for companies and flexible in
    how companies can achieve the standard. Thus, as a regulatory tool,
    HAACP sets a standard of care for implementing preventive process
    control but is inherently flexible in allowing companies to tailor
    their preventive controls to the particular hazards and circumstances
    in their operations. Performance standards for microbial contamination
    say what level and incidence are acceptable, but they do not dictate
    the interventions needed to achieve them.
        In a food safety system based on holding the industry accountable
    for prevention, regulators have a duty not only to avoid stifling
    innovation but to affirmatively encourage it. This means among other
    things ensuring that regulatory review of new food safety technologies
    is done promptly and with an appreciation of the food safety benefits
    of technological innovation.
    5. Strengthen FDA's mandate and tools for providing national leadership
            on food safety and managing a science- and risk-based
            regulatory program.
        While FDA's core role on food safety is to set and enforce
    standards, it will be effective in this role only if it operates from a
    position of strength as the Nation's leading science-based, public
    health regulatory agency. To this end, FDA should have a clear mandate
    to drive research aimed at understanding food safety problems and
    solutions and setting science-based standards. It should work closely
    with CDC, other Federal food safety agencies, and State and local
    agencies to build an integrated, national system of food safety
    protection. And it should provide scientific and policy leadership to
    develop workable approaches to risk-based priority setting and resource
    allocation across the food safety system.
                   assessment of the fda food protection plan
        The five core policy elements outlined above reflect current
    thinking about the attributes of a modern, effective food safety
    system, as that thinking has evolved through the work of NAS, GAO and
    other experts. The language of the FDA Food Protection Plan is largely
    consistent with these ideas. It speaks of addressing risks of food
    ``from production to consumption''; it makes prevention and corporate
    responsibility for prevention central themes of the plan; and it calls
    for risk-based approaches to inspection and better use of information
    to improve food safety. For this reason, the plan is a useful basis for
    discussion.
        The shortcomings of the plan lie in the specific actions it
    proposes--and fails to propose--to implement these broad ideas. While
    many of the proposed actions are worth pursuing, they do not add up to
    an effective FDA strategy to improve food safety. In general, they fall
    short of the action that is needed to establish the food industry's
    farm-to-table accountability for prevention. To illustrate this key
    point, I will review the FDA plan in light of the five core policy
    elements discussed above.
    1. Treat food safety as a farm-to-table, system-wide problem.
        While stressing the importance of a farm-to-table approach to food
    safety, the FDA plan proposes no specific actions to improve food
    safety on the farm or at retail, beyond what it is currently doing.
        At the farm level, the plan calls for FDA to meet with food
    industry representatives to strengthen ``voluntary'' prevention efforts
    and for FDA to develop guidelines for industry development of voluntary
    ``food protection plans'' for produce and other foods, but FDA has been
    meeting with the industry about produce safety for the last decade, and
    in 1998 issued non-binding ``good agricultural practice'' guidelines to
    address the microbial safety of fresh fruit and vegetables.
        Early this year, an industry trade group, the United Fresh Produce
    Association concluded that the voluntary approach was insufficient and
    called for FDA to establish mandatory, enforceable, on-farm standards
    for safe produce production, but the FDA plan is silent on this idea.
    And, while the plan calls generally for strengthening FDA's ability to
    assess and prioritize risks and identify preventive strategies, it
    contains no specific proposals for driving the research and analysis
    needed to establish enforceable food safety performance standards on
    the farm.
        On retail food safety, the plan makes several references to the
    need for dialogue with the States and localities, which play the
    frontline role on food safety in the Nation's grocery stores and
    restaurants. Such dialogue is important, but is has been ongoing for
    many years and has resulted in important collaboration through FDA's
    development and the adoption by many States of the Food Code, which is
    a model ordinance for regulating food safety at retail. In addition,
    FDA and the States collaborate on an innovative program to foster
    improvement in State and local food safety regulatory programs, based
    on uniform national standards. The FDA Food Protection Plan does not
    include ideas for improving these core FDA retail food safety programs
    or recommend any other specific actions to improve retail food safety.
        While the FDA plan lacks concrete proposals for new actions to
    address food safety risks on U.S. farms or at retail, it does call for
    a number of actions to improve FDA oversight of food imports, including
    more affirmative efforts to work with foreign governments on food
    safety, develop knowledge needed to target high-risk imports, and
    improve FDA's ability to detect problems at the port of entry. These
    ideas are positive, but, as discussed below, the report does not
    address the accountability of importers for ensuring that the food they
    import was produced in accordance with U.S. standards.
    2. Make prevention of food safety problems the central focus of the
            system.
        The FDA plan gives great prominence to the concept of prevention,
    which would be an important and positive shift in emphasis in FDA's
    food safety program, but the plan's approach is to work collaboratively
    with the industry to foster voluntary adoption of preventive control
    plans. Such voluntary efforts can contribute to progress in the near
    term to the extent those not currently following recognized ``best
    practices'' are willing to emulate leading companies that are already
    implementing state-of-the-art preventive control plans. Such voluntary
    efforts will not, however, solve the food safety problems posed by
    companies that lack market incentives or are otherwise unwilling or
    unable to bring their food safety practices up to modern standards.
    Furthermore, voluntary approaches do not provide clear public
    accountability for prevention.
        Even more fundamentally, the FDA plan does not address the agency's
    lack of a statutory mandate to make prevention the central focus of its
    program. While prevention is clearly the necessary strategy for the
    future, the basic food safety provisions of the Federal Food, Drug, and
    Cosmetic Act on which FDA relies to regulate microbial pathogens were
    enacted in 1938 and are silent on prevention. They consist instead of
    adulteration and enforcement provisions designed for reaction to
    problems and correction of them after the fact. To make prevention the
    central focus of its program, FDA should be calling for a new
    prevention mandate from Congress and the legal tools to back it up.
    3. Recognize that the primary duty for prevention falls on the food
            industry.
        Again, the FDA plan calls prominently for promotion of ``increased
    corporate responsibility to prevent foodborne illness,'' which is a
    conceptual step forward, but the proposed implementation of this
    central concept falls far short.
        In fact, rather than recognizing that all those involved in the
    food business have a prevention duty for which they should be publicly
    accountable, the FDA plan actually places the burden on FDA to
    determine case-by-case when preventive controls should be required.
    Moreover, it calls on Congress to limit FDA's power to require
    preventive controls to cases in which it can establish through
    rulemaking that a particular food has been associated with ``repeated,
    serious adverse health consequences or death.''
        Placing the burden on FDA in this fashion is the opposite of a true
    prevention strategy. It treats preventive process control as a tool for
    reacting to problems after they occur rather than a tool for
    systematically and comprehensively building prevention into the system.
    And the stringent standard for requiring preventive controls that the
    FDA plan recommends is a step backward from the legal authority that
    FDA has under current law and has used already to require HACCP for
    seafood and juice. It is far from clear whether the Office of
    Management and Budget would have cleared, or the courts would have
    sustained, FDA's seafood and juice HACCP rules had they been subject to
    the standard recommended in the FDA plan.
        The plan's lack of follow through on the principle of industry
    responsibility for prevention is evident also in its import proposals.
    These proposals focus on what FDA will do to work with foreign
    governments and to better detect problems at ports of entry, but they
    do not call for any new accountability on the part of importers to
    ensure that problems have been prevented up the supply chain to the
    point of production in the exporting country. FDA will never have
    enough resources to police and ensure the safety of imports without
    harnessing the expertise and efforts of the private sector and making a
    U.S.-based entity legally accountable for ensuring prevention is
    ``built in'' for imports, just as it should be for domestically
    produced food.
    4. Focus FDA on setting and enforcing standards that make the food
            industry accountable for prevention.
        Other than the provisions for requiring preventive controls on a
    case-by-case, reactive basis, the FDA plan does not address the need
    for setting and enforcing standards that make the food industry
    accountable for prevention. As noted earlier, the plan focuses on
    encouraging voluntary adoption of preventive controls.
        The closest the plan comes to standards and enforcement is in its
    second core element of ``intervention,'' where the plan calls for
    ``targeted, risk-based interventions to ensure that the preventive
    measures called for are implemented correctly.'' The three ``key
    intervention steps'' do not, however, directly address prevention at
    all, nor do they involve any measure that would create accountability
    for prevention. The three proposed ``interventions'' are instead tools
    for detecting problems after the fact, including risk-based inspection,
    sampling, and surveillance and improved detection of food system
    ``signals'' that indicate contamination. These are all worthy
    approaches to better targeting the use of scarce resources, but they
    are more about detection and correction of problems than prevention.
        The best way to ensure that necessary preventive measures are
    implemented is to hold companies directly accountable for prevention in
    accordance with a defined standard of care.
    5. Strengthen FDA's mandate and tools for providing national leadership
            on food safety and managing a science- and risk-based
            regulatory program.
        The FDA plan clearly envisions a food safety leadership role for
    FDA in relation to the food industry and State and local government,
    which is positive. The call for closer collaboration with State and
    local food safety agencies is especially important to building an
    effective, national food safety program and making good use of all
    available public resources. On the industry side, however, the proposed
    FDA leadership role in encouraging voluntary adoption of preventive
    controls may actually blur rather than strengthen responsibility and
    accountability for prevention.
        The plan's call for FDA leadership on food safety research and on
    developing the tools for a science- and risk-based approach to setting
    priorities and allocating resources is an important strength. The plan
    also recognizes the need for FDA to take the lead in developing the
    tools and capacity for knowledge generation and information management
    to improve food safety, such as enhancement of FDA's Emergency
    Operations Network Incident Management System, more effective traceback
    systems, and improved sharing of information across the system. Better
    collection and use of information is obviously essential to our efforts
    to improve food safety.
         recommendations for improving on the fda food protection plan
        FDA's plan has its clear strengths and weaknesses. On policy, the
    plan's major strength is that it embraces the concept of industry
    responsibility for prevention and calls for strengthening FDA's
    capacities in important ways. The plan's major policy weakness is that
    it fails to call for the statutory modernization and policy change that
    is needed to implement the prevention concept in a really substantial
    way and thus leaves FDA still relying too heavily on reaction. The plan
    does not address at all FDA's problems of dwindling resources and an
    ineffectual organizational structure for food safety.
        With these points in mind, I offer the following major
    recommendations to augment FDA's Food Protection Plan and equip FDA for
    success on food safety.
    Modernize FDA's Statutory Mandate
        Congress should modernize FDA's food safety mandate to, among other
    things:

         Explicitly make prevention of foodborne illness FDA's
    primary food safety mission;
         Establish by law a duty for all those in the food business
    to implement preventive controls appropriate to their particular
    operation, subject to FDA's implementing regulations and guidance;
         Direct FDA to establish and enforce performance standards
    that make companies accountable for implementing effective prevention
    measures;
         Make importers legally accountable for assuring that
    foreign producers and processors shipping products to the United States
    are meeting U.S. standards;
         Provide leadership in building an integrated, national
    food safety system that is science- and risk-based and makes efficient
    use of available resources to improve food safety.
    Provide FDA an Adequate and Stable Resource Base
        FDA's resources for food safety have been eroding for years as the
    agency's food safety challenge gets larger. The total operating budget
    for FDA's Center for Food Safety and Applied Nutrition--the resources
    available to take action after the staff and rent are paid--is down to
    around $25 million, which is a paltry sum for an organization charged
    with driving food safety progress across 80 percent of the American
    food supply, while also regulating dietary supplements and food
    labeling, ensuring the safety of infant formula and food additives, and
    attempting to provide food safety leadership internationally. An agency
    with all these responsibilities that can't conduct or commission
    research, adequately equip its staff, or travel simply can't do its
    job.
        Despite this well-documented resource reality, and despite the fact
    that the FDA plan includes 38 actions to strengthen FDA's food safety
    program, the plan is silent on resources. Presumably, the President's
    2009 budget proposal will include the resources needed to implement the
    plan.
        Congress, however, has a responsibility to act. In addition to
    meeting FDA's immediate needs through the 2008 and 2009 budget
    processes, Congress should undertake a serious study of how to
    establish an adequate and stable funding base for FDA's food safety
    program for the long-term. Just as it is fair to hold the food industry
    accountable for doing its food safety job, it is fair to hold FDA
    accountable for the leadership and effective action we expect from that
    agency, but only if it has an adequate and predictable resource base.
        Congress should explore a range of resource options, including:

         Requiring FDA to prepare for Congress a 5-year financial
    plan and an annual ``professional judgment'' budget sufficient to
    implement a modernized statutory mandate.
         Establishing by law a statutory inspection mandate, with
    consequences built in for failure to meet it, to serve as an anchor for
    appropriated resources.
         Authorizing FDA to collect establishment registration fees
    and import fees to provide a steady base of resources for the food
    safety program.
    Unify and Elevate the Organizational Elements of the FDA Food Safety
            Program
        The third key ingredient for the success of any agency--after an
    appropriate statutory mandate and adequate resources--is an
    organizational framework suitable for its purpose. For food safety, FDA
    needs a framework that enables it to provide national leadership on
    food safety and run a coherent, well-planned program that makes the
    best use of available resources to improve food safety. For several
    reasons, FDA lacks such a framework.
        First, within FDA, the food program has historically taken a back
    seat to the drug and medical device programs in the competition for
    management attention and resources. This is due in part to the intense
    interest that drug and device companies, health professionals, and
    patients all have in FDA's ``gatekeeper'' role for therapeutic products
    and is reflected in the fact that most FDA commissioners come from a
    biomedical or health care background. This strong tilt toward drugs and
    devices was exacerbated by the drug and device user fee laws, which
    have further focused FDA management attention, accountability, and
    resources on the therapeutic side of the agency. History has taught
    that the job of providing effective national leadership simultaneously
    on both therapeutic products and food safety is too big a job for any
    one person.
        Second, FDA's organizational structure for food safety is
    fragmented and lacks a clear focal point for leadership. CFSAN
    ostensibly has the lead on food safety at FDA, but CFSAN actually
    shares food safety jurisdiction with the Center for Veterinary
    Medicine, which regulates pet food and animal drug and feed additive
    residues in human food, and with the Office of Regulatory Affairs,
    which manages the majority of FDA's food safety resources through its
    field force of inspectors, compliance officers and laboratory
    personnel. The recent establishment in the Office of the Commissioner
    of an Assistant Commissioner for Food Protection, who serves as a
    spokesperson and coordinator but lacks budget or line authority for
    programs, further clouds responsibility and accountability for food
    safety within FDA.
        Finally, food safety leadership at FDA rests at least two
    bureaucratic layers removed from the Secretary of Health and Human
    Services. As decisionmaking in the executive branch continues to be
    centralized at higher and higher levels, with OMB having enormous
    influence on regulatory policy, the full time leader of the Nation's
    premier food safety program needs to have the greater clout in the
    system that comes from being presidentially appointed and reporting
    directly to the Secretary.
        The FDA Food Protection Plan did not address these structural
    obstacles to the success of the food safety program. Congress should
    address them by unifying the food-related components of FDA into a
    single organization and elevating that organization within HHS under
    the leadership of a presidentially appointed official reporting
    directly to the Secretary.
                                   conclusion
        Thank you again, Mr. Chairman, for the opportunity to testify on
    these important issues. I look forward to answering your questions and
    the questions of your colleagues on the committee.

        *Mr. Taylor is Research Professor of Health Policy at The George
    Washington University School of Public Health and Health Services and
    chair of the Food Safety Research Consortium. He served formerly as
    Administrator of USDA's Food Safety and Inspection Service (1994-96)
    and as Deputy Commissioner for Policy of the Food and Drug
    Administration (1991-94).

        The Chairman. Thank you very much.
        Mr. Corby.

    STATEMENT OF J. JOSEPH CORBY, DIRECTOR, NEW YORK DEPARTMENT OF
                   AGRICULTURE & MARKETS, ALBANY, NY

        Mr. Corby. I wish to offer my sincere thanks to you,
    Senator Kennedy, Senator Enzi and this committee for providing
    me the opportunity to testify today and to discuss the role of
    State and local government in our country's food safety system.
        I've spent my entire working career of over 37 years as a
    State food safety regulator for New York's Department of
    Agriculture and Markets beginning as a food inspector in 1970.
    During this time I've witnessed many changes in the manner in
    which food protection programs have been conducted within the
    country and have also seen the consequences when these programs
    become weakened or ineffective. I continue to remain optimistic
    about FDA as a partner in our efforts with food safety. Many of
    the innovative food safety programs in existence today in New
    York State, including our work with imported foods, are there
    because we established a close working relationship with FDA's
    New York district. A relationship that recognizes each others
    strengths and weaknesses and one that promotes efforts for
    working together rather than on our own.
        We certainly do not agree with FDA on all food safety
    matters. And we realize there is some bureaucratic obstacles to
    our achieving success together. But we have always remained
    close working partners on many issues and have a mutual respect
    for one another.
        My written testimony provided to the committee suggested
    that this country is looking for leadership in the arena of
    food safety and FDA must be more aggressive in developing
    strategies that will ensure consumers they continue to have the
    safest food supply in the world. I strongly believe the success
    of FDA and other food safety agencies at the Federal level
    depends on a large extent on effective coordination and
    collaboration with food safety regulators and health officials
    at the State and local level. There are more than 3,000 State
    and local agencies involved in food safety and we've long been
    on the front line in conducting foodborne illness surveillance,
    investigating and containing illness outbreaks, conducting food
    safety inspections at grower level, at processors and packers,
    at warehouses, food processing plants and retail establishments
    in taking regulatory action to remove unsafe products from the
    market.
        State and local food safety officials are much closer to
    consumers than Federal agencies and under direct pressure to
    respond to food safety concerns in their communities even when
    the problems originate elsewhere. One need only ask themselves
    who would they call when sickness associated with food strikes
    them or a member of their family. In almost every circumstance
    they would call the local health department or the State health
    department or the State Department of Agriculture, seldom do
    they call FDA. Furthermore when the news media discovers
    recalled food products still on grocery store shelves months
    after a recall was announced by a Federal agency they will
    contact local or State food safety officials and demand to know
    why.
        To many of us in State and local food safety programs, it
    appears that Federal policymakers do not have a clear
    understanding of the food safety roles of State and local
    agencies and the issues we face. The need for Federal-State
    partnership in collaboration is well recognized and often
    voiced. But absent some affirmative effort, Federal food safety
    reform is unlikely to address the roles and the needs of State
    and local agencies that are critical to achieve real progress.
        This would be so unfortunate in today's world where food
    safety and a defense of our food supply have become very much
    linked together. We must build a system that contains the
    elements of early detection, rapid response and quick recovery.
    This cannot be done in my view without the active participation
    of State and local government resources.
        I have provided the committee with a survey summary of
    State food protection programs conducted by the Association of
    Food and Drug Professionals. This survey which was conducted
    several years ago illustrates a very clear picture of the
    enormity of food safety work that is performed at the State and
    local level. What the survey reveals more than anything else
    however, is that the safety of our food supply is not a Federal
    matter only, but an issue to be dealt with by government at all
    levels in a comprehensive and coordinated fashion.
        AFDO and its State members have voiced for years the need
    for a fully integrated food safety system in this country. With
    the implementation of the new action plan set forth by FDA, the
    ability and willingness of State and local agencies is to share
    their resources and authorities and a sincere desire of FDA to
    work with their State and local partners to restore consumer
    confidence, we can build a seamless food safety system once and
    for all.
        Thank you and I look forward to your questions.
        [The prepared statement of Mr. Corby follows:]
                     Prepared Statement of J. Joseph Corby
        I wish to offer my sincere thanks to Senator Kennedy, Senator Enzi,
    and this committee for providing me the opportunity to testify before
    you and to discuss the role of State and local government in our
    country's food safety system. I have spent my entire working career of
    over 37 years as a State food safety regulator for the New York State
    Department of Agriculture & Markets (NYSDAM) beginning as a Food
    Inspector in 1970. I have witnessed many changes in the manner in which
    food protection programs are conducted within the country and have also
    seen the misfortunes of many, especially children, when these programs
    become weakened and ineffective. I have interviewed victims of
    foodborne illnesses and listened in great horror to the tragic tales of
    mothers whose children had succumbed to an illness that was hidden
    within their hamburger, vegetable salad, or apple cider. In recent
    years, I began to wonder what food would we next learn could make us
    sick and what emerging pathogen would now cause such danger and concern
    for us. It seems to me that this Nation is screaming out for leadership
    and demanding that its government build a seamless food safety system
    that will restore their confidence in the food supply and in us. This,
    in my view, is the challenge before us today.
        The success of the Food and Drug Administration (FDA) and other
    food safety agencies at the Federal level depends to a large extent on
    effective coordination and collaboration with food safety regulators
    and health officials at the State and local level. The more than 3,000
    State and local agencies involved in food safety have long been on the
    frontline in conducting foodborne illness surveillance; investigating
    and containing illness outbreaks; conducting food safety inspections at
    the processing, warehousing and retail area; and taking regulatory
    action to remove unsafe products from the market. State and local food
    safety officials are much closer to consumers than Federal agencies and
    under direct pressure to respond to food safety concerns in their
    communities, even when the problems originate elsewhere. One need only
    ask themselves who they or their doctor would call when sickness
    associated with food strikes them or a member of their family. In
    almost every circumstance, they call the local health department or the
    State health or agriculture department. Seldom do they call the FDA.
    Furthermore, when the media finds recalled food products still on store
    shelves months after a recall is announced by the FDA, the media will
    contact local or State food safety officials and demand to know why.
        To many of us in State and local food safety programs, it appears
    that Federal policymakers do not have a clear understanding of the food
    safety roles of State and local agencies and the issues we face. The
    need for Federal-State-local ``partnership'' and ``collaboration'' is
    well recognized and often voiced, but, absent some affirmative effort.
    Federal food safety reform is unlikely to address the roles and needs
    of State and local agencies with the specificity required to achieve
    real progress. This is an important concern because, like many elements
    of the public health system, State and local food safety agencies
    operate under disparate and sometimes outdated statutory authorities,
    face the challenge of working within a complex web of local, State and
    Federal agencies having complementary and sometimes overlapping roles,
    and are usually under funded.
        Notwithstanding budgetary concerns within the States, there remains
    a skillful, knowledgeable, and in many aspects untapped resource for
    the FDA to collaborate with on matters of food safety and food defense.
    In 2001, the Association of Food & Drug Officials (AFDO), the primary
    organization that represents government food safety regulators,
    conducted a survey of State food protection programs to quantify the
    amount of food safety work performed there. The survey represented all
    50 States, with at least one administrator from every State responding.
    The results clearly demonstrated how huge a role the States play in the
    overall food safety efforts that exist in this country. Appendix B on
    the last page of this document summarizes the AFDO survey.
        What is most alarming about this data is that the majority of this
    work identified at the State level may not be accepted or even
    acknowledged by Federal agencies. This is true despite the fact that
    nearly 50 percent of the food inspections claimed to be performed by
    the FDA annually are actually performed by State agencies under
    contractual agreement. While there may be a number of reasons for this
    (such as equivalency issues and differences in authorities and laws),
    in my opinion we do a great disservice to consumers by not better
    coordinating our overall food safety efforts in this country.
        Another unfortunate matter is the fact that over 320,000 food
    samples collected and analyzed by State food safety programs are, for
    the most part, ignored by Federal agencies. Again, this may be a result
    of the FDA's concern for equivalency or how samples are collected and
    processed by State officials, but it seems very unwise to ignore such a
    huge amount of important information relating to domestic and foreign-
    produced foods. Why the FDA does not better utilize this data and
    recognize its relevance to the protection of public health has remained
    a mystery to State food safety program managers for some time.
        I have had the great fortune of working for an agency that has had
    the courage to meet food safety challenges very aggressively and the
    willingness to explore innovative strategies to better deal with these
    challenges. NYSDAM has gained its national reputation in food
    protection because we recognize the value in resource integration,
    partnering with Federal agencies, and pursuing a course that recognizes
    that there is but one food supply to be protected regardless of the
    number of government agencies involved.
        There are certain components of New York State's food protection
    program that I believe forge innovative, ``cutting edge'' partnerships
    with the FDA and serve as models for other States. Our ``Integrated
    Food Safety System'' is a partnership program with the FDA's New York
    District, and perhaps most noteworthy is our Imported Food Initiative
    agreement we have with that district's Upstate and Downstate Import
    Operations.
        The purpose of the Integrated Food Safety Partnership is to
    establish an agreement that coordinates the food protection efforts of
    NYSDAM's Division of Food Safety and Inspection and the FDA's New York
    District Office. This agreement reduces consumer risk, eliminates
    duplication, defines regulatory roles and improves channels of
    communication. All manufacturing food establishments and food storage
    facilities licensed or inspected by NYSDAM are covered by this
    agreement and it serves as a pilot to demonstrate the effectiveness of
    integrating the Federal/State responsibility for the food manufacturing
    and storage industries. The partnership includes data and information
    sharing, training, recalls, and enforcement strategies. It allows the
    FDA and NYSDAM to share each other's resources and authorities. We
    could have never implemented this partnership program without mutual
    respect and the recognition that we both play critical roles in
    protecting New York citizens.
        Our Import Initiative pilot is the project of which I am most proud
    because it is most timely and truly effective in dealing with the
    overwhelming burden of imported foods. It is very clear that the number
    of goods imported into this country has increased dramatically, and the
    majority of these imports are foods (See Figure 1). The FDA's ability
    to handle the enormous surge of imported products, however, is
    increasingly limited; in fact it is estimated that less than 1 percent
    of imported products are physically examined (See Figure 2). As a
    result, the FDA is contracting out more and more domestic inspections
    to State agencies in order to focus more resources to imported
    products. Unfortunately, they cannot meet this huge demand, yet little
    has been done to allow State agencies to play a greater role in the
    surveillance and inspection of these foods. Imports have essentially
    remained a role of the Federal Government through the efforts of U.S.
    Customs and Border Protection [CBP], the U.S. Department of Agriculture
    (USDA) and the FDA. The Import Initiative, however, allows the FDA and
    NYSDAM to work more collaboratively on imported food oversight.
        This cooperative effort is essential because approximately 33
    percent of the imports coming into this country enter through New York
    State. Because of our diverse population, many of these products remain
    in New York and are marketed domestically here. These domestic
    channels--which include food warehouses, processing plants, and
    retailers--are the areas for which State and local food safety
    regulators are primarily responsible. To summarize, one can conclude
    that any imported food that makes its way through the scrutiny of the
    Federal Government becomes primarily the responsibility of State and
    local government regulators.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Note that although large volumes of imported food enter the United
    States via ports of entry in New York State, food of import origin
    offered for sale at New York wholesale/retail establishments can, and
    does, enter the United States via any of the 400+ ports of entry
    scattered throughout the country. NYSDAM's surveillance of foods of
    import origin at the wholesale/retail level not only protects consumers
    in New York State, but also provides valuable information to the FDA
    regarding how the national import program is working. Subsequent joint
    investigations of violative food product will enable the FDA to
    determine why the violative food was not detected and detained and take
    affirmative steps to do so in the future.
        A good illustration of the dilemma for State agencies with imported
    foods is depicted in Figure 3 below. This chart is a 5-year summary of
    food recalls coordinated by NYSDAM. With a field staff of a little over
    100 Food Inspectors, we are averaging over 350 food recalls a year.
    This number is greater than the number of recalls coordinated by the
    FDA and USDA annually. Of the 1,786 food recalls coordinated in New
    York since 2002, 1,304 of these (or 73 percent) involved foods of
    foreign origin. Of that amount, 1,030 (or 79 percent) were categorized
    as Class I or Class II (health impacted).

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Rather than ignore the matter or simply forward all of our concerns
    to the FDA, we decided to be more aggressive in our response. A vision
    for integrating FDA and NYSDAM resources was developed into a project
    that would allow NYSDAM to collaborate with FDA in the following three
    basic areas:
      1. Develop a Better Understanding of Laws and Authorities for Each
                                     Agency
        The FDA's strongest enforcement tool with imported food is the
    ``Import Alert'' (formerly known as ``Automatic Detention''), which
    authorizes FDA detention without physical examination when suspect
    foods, which ``appear'' to be in violation, are presented for entry
    into this country. NYSDAM's strongest enforcement authority tool is the
    ``Food Seizure'' which prohibits the commercial movement of food
    anywhere within the State. Merging and utilizing, where appropriate,
    these authorities have produced influential impact on controlling
    violative food imports.
                            2. Sharing of Resources
        NYSDAM has ample resources in domestic channels, and the FDA has
    focused resources at New York border entry points. Working jointly on
    foods of import origin in New York State at both points is optimal and
    allows the FDA to make better decisions on products to detain for
    examination at the border.
                   3. Sharing of Intelligence and Information
        NYSDAM shares inspection and sampling information relating to foods
    of import origin in domestic commerce with the FDA. Where possible, we
    also provide import entry numbers for adulterated imported foods so the
    FDA can determine which of the 400 border entry points was involved and
    the mechanism of distribution. The FDA provides immediate notice to
    NYSDAM of imported food concerns so that State inspectors can take
    prompt action in domestic channels.
        As a result of this imported food initiative, a number of very
    successful investigations have been conducted. Several of these are
    worth noting as follows:

        1. When a young female child died from choking on an imported gel
    candy product, NYSDAM received information from the FDA that 18 other
    children from around the world had met similar fates due to this type
    of product. We further learned that an ingredient in this food
    (``konjak'') prevented the candy from dissolving once placed in ones
    mouth. This information was sufficient for New York and other States to
    take immediate action against this product. In New York we coordinated
    around 54 recalls and supervised the destruction of over 60 tons of
    this product. It would have taken FDA approximately 8 months to outlaw
    the use of this ingredient in these products. The States, on the other
    hand, were able to respond quickly, and I have no doubt that our
    actions saved children's lives.
        2. An infant's sole source of food and nutrition is oftentimes the
    infant formula provided to them. Without receiving the required
    nutrition from these products, they can become ill and even die. A
    scandal existed several years ago with Chinese manufactured infant
    formula where manufacturers there were producing products absent a
    number of required nutrients, causing the deaths of a number of Chinese
    infants. The FDA advised NYSDAM that no entries for this imported
    infant formula had been listed for the country. Nevertheless, we sent
    Inspectors into Chinese-American neighborhoods, where we found this
    product. We utilized our food seizure authority, sampled and tested the
    product, and supervised its destruction following acknowledgement from
    our Food Lab that the product failed to have much of any nutritional
    value. A press release was issued through the Chinese media in New York
    City cautioning anyone who may have purchased the product. Here as
    well, I believe infant lives were saved.
        3. In this country a manufacturer of a Grade A pasteurized dairy
    product such as fluid milk or cream, yogurt or ice cream can not ship
    their products out of State or country without verification that their
    milk suppliers (dairy farmers) and manufacturing facility have received
    and passed a food safety inspection. Unfortunately, a number of
    imported Grade A dairy products are allowed to enter this country for
    marketing without the same requirement being met. States, in most
    cases, have approved source requirements for foods sold in their States
    and are able to take action against these foreign dairy firms, which do
    not have inspection verification. The FDA provides information to
    NYSDAM of where these products are shipped in New York, and we dispatch
    an inspector to the warehouse location. Products from foreign firms
    that are not inspection-verified are either exported back to the
    country of origin or removed from sale here and destroyed.

        Our imported food initiative with the FDA has been so successful
    that we have expanded the program and are now collaborating with other
    Federal agencies involved with imported foods. These include U.S.
    Customs & Border Protection (CBP), USDA's Food Safety and Inspection
    Service Import Liaison, USDA's Smuggling & Interdiction Trade
    Commission (SITC), and the Department of Homeland Security (DHS). Our
    collaborative efforts with these agencies have allowed us to take the
    following actions:

        1. Removal of illegally imported or smuggled raw poultry from China
    (avian Influenza concern).
        2. Removal of illegally imported or smuggled meats from BSE
    designated countries (BSE concern).
        3. Surveillance activities for the illegal distribution and
    marketing of African ``bush meat'' (Endangered species/potential human
    virus concern).
        Figure 4 below quantifies our imported food activity we typically
    conduct.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        The other very important element of our initiative has been the
    development of educational programs for importers, import food
    distributors, and retail food stores to assist them in protecting
    themselves from receiving adulterated or misbranded imported foods.
    These programs are especially useful to small businesses. In October of
    this year we held a program for the Chinese American business community
    and have another similar program planned for January with Russian
    American businesses.
        Our goals for this coming year is to train two additional FTE's to
    perform the inspection and investigational work associated with
    imported foods. We also hope to develop additional training courses for
    small businesses and other industry officials that distribute and sell
    imported foods. These courses will be designed to offer basic
    assistance of what food safety concerns exist with imported food
    products so that these firms can set specifications with foreign
    manufacturers to assure violative products are not delivered into the
    country. Distributors will further be trained in food labeling matters
    so they can easily detect violative concerns such as illegal food
    additives, illegal food colors, and undeclared food allergens and
    sulfating agents.
        We believe our import initiative has contributed to the adoption by
    the Federal and State regulatory agencies of the best available
    practices for controlling food safety and defense hazards associated
    with imported foods. The program leverages current Federal and State
    food safety activities to more effectively protect consumers, and it
    provides a degree of innovation.
        This kind of idea is not new, however. A program funded by the FDA
    beginning in 1998 called the ``National Food Safety System'' (NFSS) was
    intended to integrate the food safety resources of government at all
    levels. A primary objective of that project was to improve food safety
    through a collaborative effort of Federal, State and local government
    agencies. It was believed then that a fully integrated, seamless and
    science-based system would build consumer confidence and address all of
    our food safety challenges. It would be foolish to ignore some of the
    progress already in place, which resulted from the activities of the
    National Food Safety System (NFSS) project. The following are examples
    of significant NFSS accomplishments that have been achieved since the
    inception of this project in 1998:

         eLEXNET.--A secure electronic data sharing system for food
    safety laboratory data.
         ISO Accreditation.--An internationally recognized
    laboratory accreditation program aimed at assuring uniform
    methodologies for Federal, State and local laboratories.
         Directory of Laboratory Capabilities.--A compilation that
    identifies Federal, State and local laboratory capabilities in
    preparation for emergency needs.
         AFDO Recall Workgroup.--An effort involving State and
    Federal (FDA and FSIS) officials to streamline and better coordinate
    recalls for increased effectiveness in removal of contaminated product
    from the marketplace.
         Validation of Laboratory Methodologies.--A joint Federal/
    State effort to standardize and develop national rapid detection
    methods.
         Foodborne Illness Outbreak Coordination Guidelines.--
    Developed to provide uniform investigational procedures and
    information-sharing protocols.
         ORA-U.--Development of a comprehensive national training
    and certification system to better facilitate uniform food safety
    activities among all Federal, State and local field inspectors.
         Uniform Criteria Workgroup.--Development of uniform
    national regulatory standards.
         Integrated Food Safety Partnership.--A pilot program that
    integrates the food safety functions of a State and the FDA. A pilot of
    this partnership, as described above, is currently in its early stages
    of application.

        The goals of the NFSS project were to establish a system that would
    better utilize and leverage all the committed food safety resources at
    all levels of government, build uniformity and consistency with
    inspectional, analytical, enforcement and surveillance activities,
    increase the level of consumer confidence by improving food safety, and
    encourage the implementation of ONE food safety system. The projected
    roles for Federal and State agencies envisioned in this seamless food
    safety system were identified as follows:

        The Federal Government would provide oversight in the following
    areas:

         Training
         Certification
         Risk Assessment
         Program Evaluation
         Imported Foods
         Research
         Science
         Standards
         Lab Practices
         Additives
         Packaging
         Funding

        State and local government agencies would share field resources in
    the following areas:

         Inspections
         Investigations
         Complaints
         Sampling
         Analysis
         Compliance
         Enforcement

        Clearly, if we are to have a comprehensive, uniform, seamless and
    risk-based food safety system for the Nation, a development strategy
    that only examines the Federal component cannot be utilized. If it
    were, then any attempt to correct the deficiencies in the current
    system or to provide strategic plans for developing a truly effective
    national food safety system is destined to fail.
        The FDA Food Protection Plan and Action Plan for Import Safety are
    the latest efforts by the agency in setting strategies for protecting
    the Nation's food supply. These plans have great promise and both rely
    very heavily on working collaboratively with stakeholders including
    State and local agencies. The Action Plan for Import Safety speaks
    specifically for considering cooperative agreements with States. The
    Food Protection Plan uses less specific, more general language such as
    ``collaboration with'' and ``working closely with'' States in several
    areas of the document. In my opinion, FDA should strive to work more
    strategically with the States on a variety of functions including food
    safety inspections, food product surveillance, and imported food
    evaluations. In order to accomplish this, FDA would need to do the
    following:

        1. Accelerate the Manufactured Food Regulatory Program Standards
    process so more States can participate and demonstrate their
    equivalency to the FDA. The FDA can then share inspection work plans
    with State agencies to avoid duplication of efforts.
        2. The FDA must begin to accept State food laboratory analysis of
    foods so they can better work with the States on sampling assignments
    and the sharing of surveillance data. Work performed here should
    include both imported and domestic products.
        3. The FDA must improve their presence in foreign countries. By
    gaining confidence with State and local governments handling most of
    the domestic burden, FDA should be able to achieve this goal. A number
    of States are performing inspection verification for foreign dairy
    manufacturers of Grade A products. FDA should be performing these
    inspections.
        4. A number of States are leading the way in mandatory requirements
    for vegetable growers and packers. California, Florida, and Virginia
    have all introduced mandatory programs for specific commodities in
    their States. The FDA should model these programs so they become
    nationally accepted.
        5. There is a huge need to improve our response efforts with food
    recalls. Recent national recalls for peanut butter, spinach, and chili
    sauce were confusing and ineffective. North Carolina employed an
    Incident Command System [ICS] utilizing State and local government
    officials from a multitude of agencies for the chili sauce recall. They
    performed more recall audit checks in North Carolina than the rest of
    the country combined. They also found a large number of these botulism-
    tainted products in children's camps and other non-traditional food
    venues ready for sale or service. The FDA needs to review their
    response efforts with recalls and establish a formalized strategy with
    State and local government to better deal with recalls.
        6. The FDA needs to be granted recall and record review authority
    by Congress to properly function as a regulatory public health agency.

        While the country debates how to best protect our food and what
    agency and how many will lead this effort, the fact remains clear that
    whatever strategy is used the States and local agencies must be
    recognized for the critical role they play.
        Developing a new, comprehensive regulatory structure at the Federal
    level will be an enormous task. It must include elements that address
    human and animal health and nutrition, controls for foodborne
    pathogens, surveillance of potential hazards, monitoring foodborne
    illnesses, research and consumer education. Additionally, food safety
    must now be part of any national security strategy.
        Given the scope of the matter and the newfound critical importance
    of food safety and security, it is difficult to argue against the
    strategies outlined in FDA's Food Protection Plan and Action Plan for
    Import Safety. What must not be overlooked, however, is the fact that
    most of the food safety and food defense activities that occur in this
    country occur at the State and local levels. The idea that food safety
    or food defense is somehow only a Federal Government responsibility is
    grossly inaccurate and misguided. There is great need for leadership,
    however, and the FDA, assuming full implementation of these plans,
    seems well suited.
        Thank you for the privilege to present my views on these very
    important matters.
                                     ______

                Appendix B. AFDO National Survey--Survey Summary

         Food Safety Regulatory Activities Conducted by Local and State
                      Government Agencies in Year 2001 \1\
    ------------------------------------------------------------------------------------------------------------------------------------------------
    Inspections:
      Food processing/repacking facilities.....................       56,644
      Dairy plants.............................................        7,562
      Manufactured milk plants.................................        5,956
      Dairy farms..............................................      159,483
      Retail food service establishments.......................    1,178,348
      Institutional food service establishments................       51,290
      Retail food stores.......................................      516,033
      Intrastate wholesale meat processors.....................      418,844
      Custom exempt meat plants................................       12,310
      Small animal slaughter houses............................       24,395
      Feed manufacturers and distributors......................       19,904
      BSE inspections..........................................        3,475
      Rendering plants.........................................          605
      Food transportation vehicles.............................        9,481
      Food salvage operations..................................        2,067
      Farm productions (GAPS)..................................          311
      Food warehouses..........................................       20,624
      Other....................................................       15,525
                                                                ------------
        Total..................................................    2,500,857
    Investigations:
      Foodborne illness outbreaks..............................        3,075
      Tracebacks (not recalls).................................          154
      Consumer complaints......................................       46,019
      Shellfish growing areas..................................       20,870
      Commecial fishing areas..................................        5,251
      Farm pesticide residue...................................          472
      Chemical residue in meat, milk, fish, and eggs...........        7,855
      Disasters and/or emergency response......................        2,816
      Animal health matters (food safety related)..............          204
      Other....................................................        3,199
                                                                ------------
        Total..................................................       89,915
    Do high risk establishments receive more inspections per
     year than lower risk establishments?
      Yes......................................................           69
      No.......................................................           15
    Number of licensed/permitted establishments................      755,123
    Number of unlicensed/not permitted establishments..........       60,910
    Number of FTEs (field).....................................        3,685
    Number of FTEs (administrative and support)................          873
    Entry Level Requirements:
      High school..............................................           17
      Two-year college degree..................................           10
      Four-year college degree.................................           65
      Other....................................................           29
    Do you require continuing education for inspectors or
     investigators?
      Yes......................................................           55
      No.......................................................           32
    Do you require field inspectors or investigators to be
     registered?
      Yes......................................................           26
      No.......................................................           52
    Do you require field inspectors or investigators to be
     commissioned?
      Yes......................................................           20
      No.......................................................           57
    Enforcement Activities:
      Embargo/seizure..........................................       13,910
      Stop sale................................................       31,546
      Health Advisories........................................           90
      Monetary penalties.......................................        9,878
      License/permit revocation................................        2,899
      Injunctions..............................................           74
      Criminal prosecutions....................................        4,048
      Warning letters..........................................       36,346
      Informal hearings........................................        1,102
      Food recalls.............................................          660
      Other....................................................       28,537
                                                                ------------
        Total..................................................      128,430
    Laboratory Capabilities:
      Food chemistry...........................................           52
      Microbiology.............................................           63
      Pesticide residue........................................           43
    Number of samples analyzed:
      Food chemistry...........................................       59,991
      Microbiology.............................................      252,307
      Pesticide residue........................................       15,767
                                                                ------------
        Total..................................................      328,065
    ------------------------------------------------------------------------
    \1\ Association of Food and Drug Officials. State Food Safety Resource
      Survey, 2001.

        The Chairman. Thank you very much. Congressman, glad to
    have you here.

       STATEMENT OF HON. CAL DOOLEY, PRESIDENT & CHIEF EXECUTIVE
      OFFICER, GROCERY MANUFACTURERS ASSOCIATION, WASHINGTON, DC.

        Mr. Dooley. Thank you. Thank you, Mr. Chairman. I'm
    delighted to be here and I commend you for holding this
    hearing.
        You know Americans enjoy the safest food supply in the
    world, but the food companies I represent recognize that steps
    must be taken to make our food supply even safer. Ensuring the
    safety of our products is the single most important goal of the
    food industry. And our industry devotes enormous resources to
    ensure that our products are safe.
        As we've heard earlier this morning increasing imports and
    changing consumer preferences pose new challenges for food
    companies and for the FDA. To address those challenges we need
    to modernize our food safety system. At GMA, our industry has
    adopted a wide variety of preventative controls to confront the
    causes of contamination at the source. We believe that the
    prevention of contamination through the adoption of
    preventative controls should continue to be the foundation of
    our Nation's food safety strategies.
        To improve the safety of imported foods we believe that
    Congress should mandate by statute that every food importer
    implement a supplier quality assurance program based upon FDA
    guidance and subject to FDA review. Under this proposal food
    companies would have to document that their foreign suppliers
    were implementing good manufacturing practices and other
    preventative controls. We also believe that Congress should
    expand FDA's ability to develop the capacity of foreign
    governments to detect threats and to harmonize food safety
    standards.
        FDA should also be given the authority to certify the
    safety of high-risk imports, now subject to automatic detention
    and permitted to credit third party inspectors, auditors and
    labs to assist in these efforts. To improve our ability to
    detect threats at the border we believe that FDA must be given
    more resources to hire inspectors and to train other Federal
    and State officials to inspect imported foods. But we also
    believe that Congress must help focus FDA's inspections on
    those imports posing the greatest risks to human health by
    creating a voluntary program to expedite food imports posing
    little or no risk.
        To improve the safety of food produced in the United States
    we believe that Congress should permit FDA to mandate that
    fruits and vegetables be produced according to good agriculture
    practices. Rising consumption of fruits and vegetables
    represent and reflect the good news that more Americans are
    making healthier food choices, but also create new food safety
    challenges that should be addressed through strong produce
    safety standards that can be tailored to reflect differences
    among crops.
        Congress should also direct FDA to modernize preventative
    controls for packaged food products to reflect scientific
    advances. But we object to prescriptive mandatory approaches.
    Especially in light of the resource constraints at FDA that
    will undermine the scientific advances in the foundations of
    seeing the advances that could be incorporated through the
    private sector. Finally we support granting FDA the authority
    to issue a mandatory recall if a company has refused to conduct
    a voluntary recall and there is a significant risk to human
    health.
        Let me close by saying a few words about resources. A FDA
    Science Board concluded yesterday Congress and Administration
    have simply failed to provide the agency with adequate
    resources. As a result the agency lacks the scientific capacity
    to fulfill its mission. Providing FDA adequate resources to
    help defend the public from foodborne illness should be as
    fundamental as defending the public from other threats foreign
    and domestic.
        Our companies do not depend upon FDA inspections to ensure
    the safety of their products and they should not be asked to
    pay a fee because Congress and the Administration has failed to
    perform its most basic function, protecting the public. What's
    more, taxing food imports or food facilities--as some have
    proposed--to finance this basic function of government would
    inevitably fall more heavily on some countries, some companies
    and some consumers. And it would not employ a risk-based
    allocation of those fees.
        We can look to the simple fact that 33 percent of the
    imports of food products coming into the United States are
    coming from Canada. A country that has systems that are very
    similar to ours in their food safety. And if you imposed an
    import fee you would see in fact a disproportionate share of
    that cost being funded by Canada.
        I urge you to give FDA the resources and the additional
    authority needed to meet the challenges posed by rising food
    imports and changing consumer preferences. And just my last
    statement I want to make it clear, Mr. Chairman and the other
    members of the committee that I have been most pleased by the
    constructive dialogue that we have had with CSPI and Mike
    Taylor and many other groups on this. And we are committed to
    working with you to ensure that we can collectively find a
    system that really can meet the needs of consumers.
        [The prepared statement of Mr. Dooley follows:]
                   Prepared Statement of the Hon. Cal Dooley
        Good morning. I am Cal Dooley, President and CEO of the Grocery
    Manufacturers Association.
        Americans enjoy the safest food supply in the world, but food and
    beverage companies recognize that steps must be taken to make our food
    supply even safer. Ensuring the safety of our products--and thereby
    maintaining the confidence of consumers--is the single most important
    goal of the food and beverage industry. Product safety is the
    foundation of consumer trust, and our industry devotes enormous
    resources to ensure that our products are safe.
        Steadily increasing food imports and changing consumer preferences
    pose new challenges for food and beverage companies and for the Food
    and Drug Administration. In recent years, we have experienced dramatic
    changes in the volume and variety of food imports. The percent of food
    imported into the United States increased by nearly 40 percent between
    1995 and 2005 to 15 percent of the U.S. food supply. In particular,
    roughly 60 percent of the fruits and vegetables and roughly 80 percent
    of seafood now consumed in the United States are imported.
        To address the challenges posed by rising imports and changing
    consumer choices, food and beverage companies and Federal and State
    agencies have placed continually greater emphasis on the prevention of
    food contamination. By constantly identifying and addressing the
    sources of contamination throughout each product's life cycle, we
    continually reduce the risk of food-borne illness to consumers. We
    believe that the prevention of contamination--through the adoption of
    preventive controls--should continue to be the foundation of our
    Nation's food safety strategies.
        As you seek to modernize food safety legislation, we urge you to
    focus on programs and policies that will prevent food contamination and
    to consider the following recommendations. Many of these
    recommendations were included in Commitment to Consumers: the Four
    Pillars of Imported Food Safety, a comprehensive food safety proposal
    released this fall by the Grocery Manufacturers Association.
        One, we urge you to require that every food importer of record
    institute a foreign supplier quality assurance program that assures
    that all imported ingredients and products meet FDA food safety and
    quality requirements. To assist companies in developing these supplier
    quality programs, we propose that FDA issue guidance on key elements--
    including, as appropriate, audits, testing, good manufacturing
    practices, food defense programs, good agricultural practices, and
    other preventive controls. Requiring food importers to ensure the
    safety of their supply chains--and giving FDA the authority to oversee
    industry's implementation of these programs--would significantly reduce
    the likelihood of contamination.
        Two, we further urge you to expand FDA's ability to build the
    capacity of foreign governments to prevent and detect threats to food
    safety. In particular, FDA should be directed to work with foreign
    governments to expand training, accelerate the development of
    laboratories, ensure the compliance of exports with U.S. regulations,
    and harmonize food safety requirements among countries. FDA should also
    be given the authority to detain food imports if inspections of foreign
    facilities are warranted but are unduly delayed or refused, as proposed
    by FDA in the agency's Food Protection Plan.
        Three, we urge you to enhance FDA's ability to target those imports
    that pose the greatest risk to consumers. In particular, we urge you to
    create a voluntary program to permit expedited entry of foods that pose
    no meaningful risk. By permitting food importers who demonstrate the
    existence of a secure supply chain and who meet FDA's standards and
    conditions to receive expedited entry, FDA could focus more scrutiny on
    those imports that are more likely to pose a risk to public health. A
    risk-based approach to food inspections, combined with enhanced
    training of FDA and other Federal and State inspectors, would
    significantly improve our ability to detect contaminated food. In
    addition, FDA should build upon existing efforts to ensure the safety
    of imported foods from countries or companies with a history of
    problems by working with those foreign governments and food companies
    to certify the safety of such products before they are offered for
    import into the United States. Increasing our ability to scrutinize and
    oversee imports based on risk would greatly enhance our ability to
    detect threats to public health without crippling commerce or violating
    our trade commitments.
        Fourth, we urge you to take steps to continually improve the safety
    of food produced in the United States. In particular, we urge you to
    provide FDA authority to mandate that produce be produced following
    good agricultural practices. Rising consumption of fruits and
    vegetables, including ready-to-eat foods, reflects growing consumer
    demand for healthier food choices but also creates new food safety
    challenges that should be addressed through strong and enforceable
    produce safety standards which can be tailored to reflect differences
    among commodities. Similarly, we support modernizing preventative
    controls for packaged food products to reflect scientific advances and
    thereby strengthen the foundational elements of our food safety system.
    We also support proposals to require facility registrations once every
    2 years, as suggested in FDA's Food Protection Plan, and we support
    increased frequency of facility inspections, provided that such
    inspections are based upon a scientific assessment of risk and upon
    history of compliance.
        Fifth, we urge you to give FDA the authority to order a mandatory
    recall when a company has refused to conduct a voluntary recall and
    there is a significant risk to public health. Specifically, where the
    responsible party refuses to voluntarily recall a product for which
    there is a reasonable probability that the food will cause serious
    adverse health consequences or death, the Secretary should be permitted
    to order the company to conduct a recall.
        We believe the adoption of these and other recommendations
    identified in our Four Pillars proposal will, in combination, ensure
    that Americans continue to enjoy the safest food supply in the world.
    By focusing our efforts on prevention, by using limited FDA resources
    wisely, by leveraging the expertise and resources of the food industry,
    and by working in partnership with the Food and Drug Administration, we
    believe Congress can help us meet the challenges posed by rising
    imports and changing consumer preferences.
        Our industry has made substantial investments in food safety and
    has increased and will continue to increase our investments to address
    the challenges posed by rising imports and changing consumer
    preferences. We believe that Congress must also make significant new
    investments in food safety. That's why we have joined forces with
    groups like the Center for Science in the Public Interest to advocate
    for major increases in FDA appropriations. We also think foreign
    governments and suppliers should upgrade their food safety systems to
    ensure that foods exported to the United States meet our high
    standards. Although we support giving FDA more resources and more
    authority, we strongly oppose proposals to tax food companies or impose
    other fees on the food industry.
        The benefits of a safer food supply accrue to the public generally,
    much like the benefits of a strong national defense. A user fee is
    appropriate when the benefits of the government service flow to an
    individual (such as recreation fees, public transportation, or postage
    stamps) or to a particular business (such as harbor maintenance fees,
    accelerated review of prescription drugs, or bankruptcy filing fees).
    But, the benefits of inspections, effective science-based standards,
    and research and enforcement flow to all Americans, not simply to food
    companies. What's more, such taxes or fees will fall unequally on some
    companies--and, ultimately, on some consumers--and could violate our
    trade commitments, inviting reciprocal taxes and fees on U.S. food
    exports.
        The food industry is eager to work with Congress to craft
    modernized food safety legislation that makes the prevention of
    contamination the foundation of our food safety system and which builds
    upon a public-private partnership between the food industry and the
    Food and Drug Administration.

        The Chairman. Thank you very much.
        Ms. DeWaal.

       STATEMENT OF CAROLINE SMITH DEWAAL, FOOD SAFETY DIRECTOR,
      CENTER FOR SCIENCE IN THE PUBLIC INTEREST, WASHINGTON, DC.;
          ACCOMPANIED BY DAVID PLUNKETT, SENIOR STAFF ATTORNEY

        Ms. DeWaal. Thank you very much. This is not a tragedy for
    my children, but it definitely is because it is such an
    important day. David Plunkett, senior staff attorney will give
    my remarks and then I'll preserve my voice for questions if
    there are any.
        The Chairman. Ok.
        Mr. Plunkett. Thank you Mr. Chairman and Senator Enzi for
    calling this hearing for giving us an opportunity to testify on
    behalf of consumers.
        Late last week science advisors to the FDA released a
    report indicating that the agency is in dire need of a modern
    mission and sufficient resources to make its food safety
    program credible. Given the numerous foodborne illness
    outbreaks and recalls over the last 18 months from spinach,
    lettuce, peanut butter, pet food, canned chili and others
    together with these expert evaluations, the timing is excellent
    to put forward fundamental reform of FDA's food program on
    Congress' agenda for next year.
        While FDA's food protection plan clearly signals the end of
    the Administration's willingness to make changes in order to
    restore credibility to FDA's program, Congress must go beyond
    the limited reforms contained in the plan. CSPI recently
    released a white paper, building a modern food safety system
    for FDA-regulated foods, that's included in our testimony, that
    lays out the principles of comprehensive food safety reform.
    Congress passed several important food safety reforms when it
    passed the Bioterrorism Act in 2002. Unfortunately, those
    reforms were not effective enough to ensure discovery of an
    intentionally contaminated ingredient that would ship to the
    United States--incorporated widely in pet food. The next
    disaster might be worse affecting humans as well as their pets.
        In the Food Protection Plan the legislative authority
    proposed by FDA is too narrowly targeted to effectively address
    today's food safety challenges. Congress can learn from the
    past and adopt comprehensive food safety reform.
        The heart of any effective reform effort lies in
    prevention. Congress should require every food plant regulated
    by FDA to have food safety plans that demonstrate the companies
    are aware of potential hazards and are taking steps to avoid
    them. This would mean the companies that rely on ingredients
    would have to exercise due diligence to ensure those products
    have not been tampered with or otherwise arrived contaminated
    whether they are from domestic or imported sources. Food safety
    plans help ensure safe production and should be a prerequisite
    for all food processors both domestic and foreign. Under a
    modern statute these plans would also form the basis for food
    safety audits and inspections done by the Federal Government.
        The gaps in FDA's food protection plan are numerous. It
    puts the burden on FDA to determine risk before requiring
    process control programs. It does not provide adequate
    inspection authority. It fails to require certification of
    foreign facilities. It exempts farms. And it does not provide
    for traceability.
        The plan would do little to address the problems with
    contaminated spinach, lettuce and peanut butter that led to so
    many illnesses and hospitalizations or even melamine-tainted
    wheat gluten that resulted in the massive recall of pet food.
    It simply does not go far enough to address the very real
    problems with a food supply that U.S. consumers have
    experienced over the last 18 months, problems that have
    resulted in a 16 percent decline in consumer confidence.
        U.S.-food safety laws are antiquated and were never
    designed to deal with modern issues such as escalating imports,
    bioterrorism, or tainted produce. The recent outbreaks serve as
    a reminder that much is needed to protect the food supply.
    Congress needs to enact a food safety program that puts public
    health at the forefront of food safety in America.
        On behalf of the 900,000 consumers, represented by CSPI, we
    urge Congress to go beyond the incremental changes proposed in
    the food protection plan and adopt comprehensive reforms to
    modernize food safety laws in the United States.
        [The prepared statement of Ms. DeWaal follows:]
                  Prepared Statement of Caroline Smith DeWaal
        My name is Caroline Smith DeWaal, and I am the director of food
    safety for the Center for Science in the Public Interest (CSPI). CSPI
    is a non-profit health advocacy and education organization focused on
    food safety, nutrition, and alcohol issues. CSPI is supported
    principally by the 900,000 subscribers to its Nutrition Action
    HealthLetter and by foundation grants. We accept no government or
    industry funding.
        Thank you for the opportunity to address this committee and comment
    on the Food and Drug Administration's (FDA) Food Protection Plan.
    Before getting to FDA's new plan, I would like to provide some
    background. In the 2002 Public Health Security and Bioterrorism
    Preparedness and Response Act (``Bioterrorism Act''), Congress passed
    new authorities designed to increase FDA's ability to prevent
    intentionally contaminated food from reaching U.S. consumers. These new
    authorities included mandatory registration of domestic and import food
    facilities, prior notice for import food shipments, enhanced
    recordkeeping and administrative detention. Despite mounting evidence
    at that time that FDA's legal authorities were inadequate to address
    the threat, Congress chose in 2002 to apply a targeted approach, adding
    these few additional authorities, instead of tackling the more
    difficult job of enhancing FDA's overall mission to ensure food safety
    and food protection. Unfortunately, that approach failed to prevent the
    many food outbreaks and recalls of the last year, including one
    involving a toxic substance intentionally applied to a food ingredient
    regulated by FDA.
        Since September 2006, nationwide outbreaks of foodborne illnesses
    and subsequent recalls have exposed glaring holes in the safety net
    guarding U.S. consumers from contaminated food. Spinach contaminated
    with a deadly strain of E. coli; peanut butter with Salmonella; canned
    chili with Clostridium botulinum; pet food with toxic chemicals--these
    were not isolated events. FDA-regulated foods are responsible for many
    outbreaks each year as documented in CSPI's Outbreak Alert database.\1\
    But each of these tragedies in 2006-2007 demonstrated a distinct gap in
    FDA's system for regulating the food supply that underscores the need
    for farm-to-table reform.
    ---------------------------------------------------------------------------
        \1\ Center for Science in the Public Interest, Outbreak Alert!
    Database, 2007 at http://www.cspinet.org/foodsafety/outbreak/
    pathogen.php.
    ---------------------------------------------------------------------------
        Today FDA's ability to protect the food supply is being questioned
    by consumers and Congress alike. Overall consumer confidence in FDA has
    plummeted. A Harris Poll has documented that those who thought FDA was
    doing an ``excellent'' or ``good'' job went from 61 percent in 2000 to
    36 percent in 2006. In addition, over the last year, consumers' overall
    confidence in the safety of foods has fallen dramatically. The Food
    Marketing Institute reported a 16 percent decline in consumer
    confidence in the safety of food they purchase at grocery stores,
    according to its annual survey. USA Today reported in July that 83
    percent of shoppers were concerned about food from China, and 61
    percent about food from Mexico.\2\ And based on many supermarket
    conversations, these concerns have affected purchasing behavior as
    well.
    ---------------------------------------------------------------------------
        \2\ Elizabeth Weise, Buying Only U.S. Food is a Tall Order, USA
    Today, July 10, 2007, available at http://www.usatoday.com/news/health/
    2007-07-10-american-goods_N.htm.
    ---------------------------------------------------------------------------
        This loss of consumer confidence has palpable effects on food
    suppliers as well. After the spinach scare of 2006, spinach farmers
    reported losing $350 million, and had still not recovered when a second
    leafy green outbreak occurred in August of this year.\3\ But these
    outbreaks were entirely predictable--and preventable--if FDA had the
    resources to look beyond the next crisis and the authorities to compel
    the food industry to take steps to prevent problems before they occur.
    ---------------------------------------------------------------------------
        \3\ Elizabeth Weise & Julie Schmit, Spinach Recall: 5 Faces. 5
    Agonizing Deaths. 1 Year Later., USA Today, Sept. 20, 2007, available
    at http://www.usatoday.com/money/industries/food/2007-09-20-spinach-
    main_N.htm.
    ---------------------------------------------------------------------------
        CSPI applauds FDA for putting forward its Food Protection Plan and
    for finally signaling to Congress the need to give FDA additional
    authorities. But Congress should recognize that this plan outlines only
    a few incremental steps that are not sufficient to prevent the food
    safety problems consumers experienced just last year. Reforming our
    outdated food safety laws could have tremendous public health benefits,
    as each year 76 million Americans experience foodborne illnesses that
    hospitalize 325,000 and result in 5,000 deaths.\4\ It is time for
    Congress to institute real solutions--not stop-gap measures that will
    fall short in a few years time.
    ---------------------------------------------------------------------------
        \4\ Paul S. Mead, et al., Food-Related Illness and Death in the
    United States, 5 Emerging Infection Diseases 607, Sept.-Oct. 1999.
    ---------------------------------------------------------------------------
        FDA's Food Protection Plan calls for several authorities that CSPI
    has long advocated, like mandatory recalls, and proposes changes to
    address shortcomings in the implementation of the Bioterrorism Act's
    food facility registration program. But its shortcomings are numerous:

         It is not enough to ask for new authority to mandate
    recalls but fail to ask for authority to require traceability standards
    and impose civil penalties so that recalls are effective.
         It is not enough to require strict food security plans but
    fail to require food safety plans that would protect the public from
    the inadvertent contamination of food that annually sickens and kills
    so many Americans.
         It is not enough to identify a need for the full life-
    cycle approach to food safety but fail to ask for authority to
    implement programs on the farm or in the country of origin.

        In sum, the Food Protection Plan underscores the need for reform,
    but Congress must take stronger action if it is to ensure the safety of
    the food supply and protect Americans from preventable illnesses and
    deaths.
        100-year-old food safety laws create confusion and inefficiency
        Today, our Federal food safety system functions under two distinct
    statutory frameworks: one in operation at the U.S. Department of
    Agriculture (USDA) and another at FDA. USDA has responsibility for the
    safety of meat, poultry and certain egg products, covering about 20
    percent of the food supply. Its statute provides for carcass-by-carcass
    inspection in all meat and poultry slaughter plants and daily
    inspection in meat and poultry processing plants using government-
    funded inspectors. The Federal Food, Drug and Cosmetic Act and the
    Public Health Service Act give FDA responsibility for regulating the
    safety of the remaining 80 percent of the food supply, but the statutes
    are reactive, giving the agency authority to act principally when food
    is found to be ``adulterated'' or ``misbranded.'' Plants that produce
    products regulated by both agencies see a stark disparity between the
    programs, as when a frozen pepperoni pizza processing line regulated by
    USDA is subject to daily inspections, while a frozen cheese pizza line
    in the same plant is inspected by FDA about once every 10 years.
        The disparity carries over into the programs that are responsible
    for ensuring the safety of imported foods--a key concern driving
    delivery of FDA's Food Protection Plan. While USDA has a fairly
    intensive program for ensuring the safety of imported meat and poultry
    products, FDA's program is anything but comprehensive. Unlike USDA, FDA
    does not evaluate national programs to determine equivalence or visit
    foreign countries to verify compliance with food safety procedures.\5\
    Instead the agency relies on border inspections, but has the capacity
    to inspect only 1 percent of food at the U.S. border. Although imports
    of FDA-regulated foods have more than doubled in the last 7 years--from
    4 million shipments in 2000 to approximately 9 million shipments in
    2006--the rate of inspections has remained woefully low.\6\ Of these 9
    million shipments, only 0.2 percent were analyzed in a laboratory as
    part of its inspection process.\7\
    ---------------------------------------------------------------------------
        \5\ FDA's Import Program System Information Web site does not
    delineate an audit system for imported product and directs users to
    cross-reference the U.S. Customs Office for additional requirements.
    FDA Office of Reg. Affairs, Import Program System Information, (Sept.
    21, 2004), at http://www.fda.gov/ora/import/ora_import_system.html.
        \6\ Alexei Barrionuevo, Food Imports Often Escape Scrutiny, N.Y.
    Times, May 1, 2007, at http:
    //www.nytimes.com/2007/05/01/business/01food.html.
        \7\ Id.
    ---------------------------------------------------------------------------
        As with domestic food safety programs, import programs sometimes
    overlap, but resources are not shared. For example, USDA and FDA
    inspect food imports at 18 ports, but they do not share inspection
    resources at these locations. In fact, according to the Government
    Accountability Office, some USDA-approved import inspection facilities
    store FDA-regulated products, and although USDA maintains a daily
    presence at these facilities, FDA products can languish at the port
    waiting for FDA inspectors.\8\ When it comes to authority and
    resources, FDA remains the neglected stepchild of our food safety
    system.
    ---------------------------------------------------------------------------
        \8\ Gen. Acct. Off. Rep. No. GAO-07-449T, Federal Oversight of Food
    Safety: High-Risk Designation Can Bring Needed Attention to Fragmented
    System, (Statement of David M. Walker, Comptroller General of the
    United States) (Feb. 8, 2007).
    ---------------------------------------------------------------------------
          emerging hazards and intentional threats to the food supply
        One of the most-widely discussed food safety catastrophes this year
    began in March when pet food manufacturers recalled more than 100
    brands of cat and dog food after receiving complaints of cats and dogs
    developing sudden kidney failure from eating pet food. For weeks after,
    new brands were pulled from shelves as processors tracked the tainted
    ingredient--wheat gluten.
        FDA investigations revealed that the pet foods that sickened so
    many pets were contaminated with melamine and cyanuric acid, two
    industrial chemicals. These toxins were found in wheat gluten imported
    from China and used in many pet food and animal feed products
    manufactured in the United States. Chinese wheat gluten producers are
    believed to have intentionally contaminated the product with melamine
    to give the appearance of increased protein content. According to an
    investigation by The New York Times, cutting grain products with
    melamine to fool protein tests is common practice among producers in
    China, yet the contaminated wheat gluten passed across our borders
    without being found or stopped by FDA.\9\
    ---------------------------------------------------------------------------
        \9\ David Barboza & Alexei Barrionuevo, Filler in Animal Feed Is
    Open Secret in China, N.Y. Times, April 30, 2007, at http://
    www.nytimes.com/2007/04/30/business/worldbusiness/30food.html.
    ---------------------------------------------------------------------------
        Tracing the pet food back through its supply chain, FDA eventually
    identified the Chinese company that shipped the adulterated wheat
    gluten into the United States. According to reports, however, the
    company was little more than two rooms adjoining a warehouse in
    China.\10\ Clearly the registration of importers, even coupled with
    prior notice, was not sufficient to prevent the importation of this
    purposefully contaminated product. FDA needs much stronger authorities.
    ---------------------------------------------------------------------------
        \10\ David Barboza, Clues to Pet Food Recall Traced to Chinese
    City, Int'l Herald Tribune, April 11, 2007, at http://www.iht.com/
    articles/2007/04/11/asia/gluten.php.
    ---------------------------------------------------------------------------
        In 2004, Tommy G. Thompson, the former Secretary of Health and
    Human Services, expressed deep concern, saying that he was ``shocked''
    that terrorists had not struck the Nation's food supply ``because it is
    so easy to do,'' and that he ``worried every single night'' about food
    safety.\11\ We share his concern, and hope that Congress treats the pet
    food contamination incident earlier this year as a ``wake up call.'' It
    could have been much worse if instead of melamine, a more potent
    chemical was applied to a food ingredient widely used in the human food
    supply. The United States should adopt modern systems that prevent or
    promote early discovery of such problems, rather than relying on FDA's
    limited ability to respond to food safety emergencies.
    ---------------------------------------------------------------------------
        \11\ Tommy Thompson Resigns From HHS, The Wash. Post, Dec. 3, 2004.
    ---------------------------------------------------------------------------
                 shortfalls in resources and authorities at fda
        Imports are not the only food safety challenge facing FDA.
    Outbreaks linked to fresh spinach and lettuce and processed peanut
    butter and canned chili in 2006 and 2007 are just the latest symptom of
    an agency that is overwhelmed by responsibility, but lacking the staff
    and resources to function effectively. Current FDA funding shortfalls
    have reached a critical level and budget cuts have left the agency with
    fewer inspectors, even as the workload continues to increase. Since
    1972, domestic inspections conducted by FDA declined 81 percent.\12\
    Just since 2003, the number of FDA field staff dropped by 12 percent,
    and between 2003 and 2006, there was a 47 percent drop in Federal
    inspections.\13\ These declines in inspectors and inspections can be
    traced to an ongoing funding shortfall in the food safety program
    estimated in the hundreds of millions of dollars.\14\
    ---------------------------------------------------------------------------
        \12\ House Comm. On Gov't Reform, Fact Sheet: Weaknesses in FDA's
    Food Safety System, (October 30, 2006), 2, available at http://
    oversight.house.gov/documents/20061101115143-67937.pdf.
        \13\ Andrew Bridges & Seth Borenstein, AP Investigation: Food
    Safety Inspections Lanquish, Associated Press, February 29, 2007,
    available at http://abcnews.go.com/Health/wireStory?id=2905819.
        \14\ Last year, one FDA budget official estimated a funding
    shortfall in the food safety program of $135 million, which he
    described as equivalent to a 24 percent budget cut. House Comm. on
    Gov't Reform, supra at 2.
    ---------------------------------------------------------------------------
        The Peter Pan peanut butter outbreak and recall shows the
    consequences of this gap in inspection capacity and the inadequacy of
    FDA's Food Protection Plan. Last winter, the Centers for Disease
    Control and Prevention determined that Salmonella-contaminated peanut
    butter was responsible for causing illness in over 600 people in 47
    States. This outbreak could likely have been prevented with a more
    robust inspection program at FDA.
        In 2005, FDA inspected the ConAgra facility where the peanut butter
    was produced because of complaints about conditions at the plant. The
    inspectors learned from plant managers that the company had destroyed
    some product due to ``microbial problems'' in 2004, but the managers
    did not disclose the problem was Salmonella contamination.\15\ When
    FDA's oral request for documents from the plant went unanswered, FDA
    did not follow up until 2007 when the agency conducted inspections of
    the plant during the outbreak investigation.\16\ This is unacceptable
    both to Congress and to consumers.
    ---------------------------------------------------------------------------
        \15\ The plant manager stated the FDA would have to submit a
    written request if it wanted more information on the incident. See,
    Joseph S. Enoch, FDA Failed to Follow Up on 2004 Peanut Butter
    Contamination, ConsumerAffairs.com, Oct. 19, 2007, at http://
    www.consumer
    affairs.com/news04/2007/10/peanut_butter_recall17.html.
        \16\ Marion Burros, Who's Watching What We Eat, N.Y. Times, May 16,
    2007, at http://www.nytimes.com/2007/05/16/dining/16fda.html.
    ---------------------------------------------------------------------------
        The legal structure of the current system tilts Federal food safety
    resources toward USDA. While USDA regulates the 20 percent of the food
    supply known to cause 27 percent of attributed outbreaks, its food
    safety appropriations are double that given to FDA.\17\ This is due
    primarily to the legal requirements that the meat and poultry products
    regulated by USDA must be approved before sale, while foods regulated
    by FDA do not require pre-market approval.\18\ USDA employs more than
    7,600 \19\ inspectors who are stationed in 6,282 establishments to
    carry out its inspection mandate.\20\ FDA, meanwhile, has fewer than
    2,000 inspectors who are spread over 210,000 domestic food processors
    and warehouses.\21\
    ---------------------------------------------------------------------------
        \17\ Center for Science in the Public Interest, Outbreak Alert!,
    Dec. 2006, 2, at http://www.cspinet.org/foodsafety/outbreak_alert.pdf.
        \18\ The differences between USDA and FDA regulatory authorities
    are detailed in ``Overseeing the U.S. Food Supply: Steps Should be
    Taken to Reduce Overlapping Inspections and Activities,'' Gen Acct Off
    Rep. No. GAO-05-549T (May 17, 2005).
        \19\ USDA, Farm Bill Forum Comment Summary and Background: Food
    Safety, (undated) at http://www.usda.gov/documents/FOOD_SAFETY.doc.
        \20\ USDA, FY 2008 Budget Summary and Annual Performance Plan, 59,
    available at http://www.obpa.usda.gov/budsum/fy08budsum.pdf.
        \21\ FDA, Food Protection Plan, (Nov. 2007) 6.
    ---------------------------------------------------------------------------
        Unfortunately, the Food Protection Plan does not address these
    problems, and could in fact add new ones. The requirement that foods
    only come under process control programs if they have been linked to
    ``repeated, serious adverse health consequences or death'' could
    potentially block needed action on foods like peanut butter and
    spinach, where outbreaks are rare. By putting the burden on FDA rather
    than the food industry, this standard could stop FDA from taking
    necessary action to address problems by requiring preventive control
    systems.
        In summary, FDA's Food Protection Plan falls short of the
    transformative reforms that are needed to remedy the shortfalls in
    resources and antiquated authorities at FDA. Congress should implement
    comprehensive reform of FDA's statutory mandate in order to better
    protect the American public.\22\
    ---------------------------------------------------------------------------
        \22\ While food safety problems have garnered the most attention,
    many other parts of the agency's responsibilities are not getting
    adequate attention--issues such as obesity, the safety of dietary
    supplements, and appropriate oversight of new technologies. In cases
    like the Castleberry botulism recall, inspectors are literally taken
    off other tasks to meet emergency needs.
    ---------------------------------------------------------------------------
          cspi's principles for modernizing fda's food safety mandate
        The timing is excellent to put fundamental reform of FDA's food
    program on the agenda of Congress over the next 12 months. A Sense of
    Congress included in the recently enacted Food and Drug Administration
    Amendments Act states Congress's readiness to adopt a modern regulatory
    oversight program and fund it adequately to fulfill its mission.
    Additionally, the emergence of coalitions of traditionally estranged
    consumer and industry organizations, like the Coalition for a Stronger
    FDA and the FDA Alliance, gives Congress a unique opportunity to appeal
    to many constituencies as it rebuilds the agency.
        While the Food Protection Plan clearly signals the Administration's
    willingness to make changes in order to restore consumer confidence,
    Congress must enact more comprehensive reform than those contained in
    the Food Protection Plan. CSPI's recently released white paper,
    ``Building a Modern Food Safety System: For FDA Regulated Foods,'' lays
    out the principles of comprehensive food safety reform. To meet the
    need for prevention, intervention and response, Congress should require
    food safety process control programs for all food processors that meet
    performance standards established by FDA. Regular risk-based
    inspections by FDA would ensure that food facilities are following good
    safety practices and meeting the safety standards set by the FDA. Under
    CSPI's principles, the registration program for importers would be
    joined to a certification process to ensure foreign producers are
    meeting the same standards as their U.S. competitors. A strong research
    component is also necessary, as is a requirement that FDA build a
    strong on-farm safety program. Finally, CSPI urges Congress to give FDA
    five new enforcement authorities: (1) mandatory recall, (2) effective
    and mandatory traceability, (3) detention authority, (4) civil and
    criminal penalties, and (5) whistleblower protection.
        The legislative authority sought by FDA is too narrowly targeted to
    encompass the principles that are critically important to comprehensive
    food safety reform. The heart of any effective reform effort lies in
    prevention, not response. Congress should require every food plant
    regulated by FDA to have food safety plans, like HACCP,\23\ that
    demonstrate the companies are aware of potential hazards and are taking
    steps to avoid them. This is already a requirement for all meat and
    poultry plants, and it should be a prerequisite for all food processors
    that want to sell food in the United States. This provides the basis
    for establishing the industry's fundamental responsibility for ensuring
    food safety.
    ---------------------------------------------------------------------------
        \23\ Hazard Analysis and Critical Control Points.
    ---------------------------------------------------------------------------
        The gaps in the FDA's Food Protection Plan are both numerous and
    dangerous: it puts the burden on FDA to determine risk before requiring
    process control programs; it does not provide adequate inspection
    authority; it fails to require certifications of foreign facilities; it
    exempts farms; and it does not provide for traceability. The plan would
    do little to address the problems with spinach, lettuce, peanut butter,
    or even melamine-tainted wheat gluten. It simply does not go far enough
    to address the very real concerns with the food supply that U.S.
    consumers have faced over the last 18 months.
        U.S. food safety laws are more than a century old and were not
    designed to deal with modern issues such as escalating imports,
    bioterrorism, or tainted produce. The heightened awareness of terrorism
    over recent years has demonstrated the need for enhanced national
    security, and the recent outbreaks serve as a reminder that much more
    must be done to protect the food supply. Congress needs to enact a food
    safety program that puts public health at the forefront of food safety
    in America. On behalf of the 900,000 consumers represented by CSPI, I
    urge Congress to go beyond the incremental changes proposed in the Food
    Protection Plan and adopt comprehensive reforms to modernize food
    safety laws in the United States.

        The Chairman. Thank you very much.
        Dr. Young.

       STATEMENT OF PAUL YOUNG, Ph.D., SENIOR MARKETING MANAGER,
              WATERS CORPORATION, NEWTOWNARDS, N. IRELAND

        Mr. Young. Mr. Chairman, Senator Enzi, members of the
    committee, I'd like to thank you very much for giving me the
    opportunity to testify today. I consider it a great honor and
    particularly, Mr. Chairman, as you have already pointed out
    that Waters Corporation is based in your own constituency of
    Massachusetts. Despite taking my position, my current position,
    with Waters in March of this year, I am still currently based
    in Ireland where I have worked for more than 25 years as a
    scientist involved in the regulation of food safety of food
    destined for the European market.
        Effective food safety control within a country requires not
    only a comprehensive set of standards but also significant
    collaboration. That involves collaboration between governments
    and producers, but also needs to involve the processors, the
    importers, the exporters. Indeed we in Waters acknowledge that
    we also have an important role to play in delivering purposeful
    innovations that address the needs of the scientist's tasks
    with monitoring the compliance with food safety regulations.
        Regulation of food safety standards of imported food
    present yet another set of challenges. In an ideal world all
    countries would apply and enforce the same set of standards for
    food production. Indeed this is the goal of the Codex
    Alimentarius Commission. Unfortunately however, the Codex
    standards are not regarded as being comprehensive enough and as
    a result individual countries or regions have independently
    developed their own specific standards for imported food.
        Faced with known harmonized country specific regulations,
    producers in exporting countries tend to focus on producing
    food under schemes designed to meet the requirements of the
    intended recipient country. For example, one producer may
    entirely focus on producing food under conditions that meet the
    demands of the Japanese import regulations that we heard the
    Congressman talk of earlier.
        Japan relies very heavily on imports for more than 60
    percent of all of the food consumed in the country. Faced with
    a high level of food contamination the Japanese recently
    revised their food standards and simultaneously placed the onus
    on importers to ensure that imported food meets these new
    standards. Compliance is monitored through an import testing
    program in which approximately 10 percent of all of the food
    consignments undergo laboratory analysis.
        The European Union has adopted a more comprehensive farm-
    to-table approach as we've heard mention of earlier. This
    applies to all domestic production. As a prerequisite for
    accepting imported food the EU demands that the exporting
    country demonstrate equivalence with EU regulations. In this
    way the EU approves countries and establishments for listed
    commodities. These approvals are subject to satisfactory
    inspection audits, carried out by the EU Commission.
        In addition to regular inspection visits, compliance is
    monitored through an import testing program. With non-compliant
    findings being communicated through a rapid alert system to all
    EU member states. The member states can then use this
    information for recall if that action is required, but also to
    stimulate increased vigilance. Faced with these differing
    standards exporters will endeavor to meet the demands of their
    chosen export markets.
        However, difficulties are likely to arise when new
    standards are ambiguous or are not clearly defined and
    enforced. In the past I have read a seafood export action plan
    that clearly stated that if product was found to be
    noncompliant with EU standards than it could be sold into
    markets where the regulations were less stringent. This may
    sound shocking but different countries assess risk in different
    ways and the EU applies the precautionary principle as is their
    right under the SPS, the Sanitary and Phytosanitary Agreement.
    But the application of this in other countries may be neither
    uniform nor clearly stated.
        In short, ensuring food safety requires collaboration
    between all interested stakeholders. This includes governments,
    producers, processors, and technology leaders. We've heard that
    word collaboration quite a lot today, but I also believe
    there's a serious risk that voluntary compliance may be
    interpreted as being optional and regarded as representing less
    stringent regulations.
        Regulation alone cannot ensure that the food supply is
    safe. This must be backed up by a well-resourced and robust
    monitoring program. In this regard technology leaders such as
    Waters also have responsibility to take part in these
    discussions to ensure that our innovations are purposeful and
    adequately address the challenge at hand. Ensuring food safety
    is about protecting consumers first and foremost. But it also
    plays a key role in maintaining consumer confidence and thereby
    protecting the interests of our producers and their integrity
    of their export markets.
        Thank you once again for the opportunity to be here today.
    And I will be happy to field any questions the committee might
    have.
        [The prepared statement of Dr. Young follows:]
                      Prepared Statement of Paul B. Young
                            about waters corporation
        For 50 years, Waters has developed innovative analytical science
    solutions to support scientists around the globe who focus on meeting
    the stringent laboratory demands for food safety regulation and
    analysis.
        Waters Corp., a publicly traded corporation (NYSE:WAT)
    headquartered in Milford, MA, holds worldwide leading positions in
    three complementary analytical technologies--liquid chromatography,
    mass spectrometry, and thermal analysis. Specifically, the company
    designs, manufactures, sells and services ultra performance liquid
    chromatography (UPLC), high performance liquid chromatography (HPLC),
    chromatography columns and chemistry products, mass spectrometry (MS)
    systems, thermal analysis and rheometry instruments.
        In addition to providing solutions in food safety, Waters creates
    business advantages for laboratory-dependent organizations by
    delivering sustainable scientific innovation to enable advancement in
    healthcare delivery, environmental management, and water quality.
    Waters products are used by pharmaceutical, life science, biochemical,
    industrial, academic and government organizations working in research
    and development, quality assurance and other laboratory applications.
        Waters Corp. employs approximately 4,700 employees worldwide,
    operating in 27 countries.
                              summary of statement
        The global trade in food is increasing significantly, such that
    governments no longer have direct control over the production standards
    employed for much of the food consumed by their citizens. While
    governments do have a responsibility to promote and permit
    international trade, they also have a responsibility to protect the
    health of their citizens from the presence of potentially harmful
    contaminants in the food supply.
        The Codex Alimentarius Commission was set up in 1963 by the Food
    and Agriculture Organisation (FAO) and the World Health Organisation
    (WHO) with the aim of developing harmonized food standards and
    guidelines. Codex therefore acts as a central point of reference with
    respect to food standards; however, it is generally believed that the
    current Codex standards lack sufficient scope to be either universal or
    comprehensive. Also, the implementation/enforcement of standards varies
    significantly from one country to another.
        As a consequence, governments have been compelled to develop
    mechanisms to ensure that imported food and feed does not pose a hazard
    to the health of humans or animals.
        These systems prove to be most effective when they involve
    collaboration of numerous bodies and organisations. This includes
    collaboration between governments and collaboration between regulatory
    authorities, producer organisations and technology providers (such as
    Waters Corporation) working together, ensuring that solutions are
    effective, robust and cost effective.
        FDA currently regulates domestic food production, but has little
    control over the production standards employed for imported food. The
    European Union (EU) concluded that relying on voluntary compliance did
    not afford adequate assurances of protection and adopted an approach of
    licensing third countries and the individual food producing
    establishments therein. This involves frequent inspection audits of
    each country, examining the food safety regulations and the
    implementation of those regulations, to ensure that food destined for
    the EU is produced under rules that afford equivalent guarantees to
    those afforded by EU regulations. Compliance with these requirements is
    monitored through the implementation of an import testing programme,
    which includes, documentary checks (ensuring that food comes from an EU
    approved establishment), physical checks and laboratory examination.
    Non-
    compliance can result in withdrawal of permission to export to the EU.
        In response to complaints from consumer organisations in 2002
    regarding the presence of contaminants in imported food, the Japanese
    Government reviewed and revised The Food Safety Basic Law and the
    standards set for food safety. Initially the Japanese Government did
    not adopt a policy of third country approval/licensing, but rather
    placed the onus on the importers to ensure that imported food was
    compliant with the new Japanese food safety standards. Additionally,
    the new regulations imposed a mandatory requirement on importers to
    have new food imports tested to demonstrate that it met the standards.
    Compliance with these standards is assured by a high level of
    laboratory testing for a very wide array of chemical contaminants,
    which is carried out by the Japanese Government during importation.
    More than 10 percent of all Japanese food import consignments undergo
    laboratory testing. Subsequently the Japanese Government has begun
    licensing foreign establishments for some high-risk commodities.
        Faced with the differing import requirements of each country/
    region, exporting producers tend to focus on meeting the demands of
    their chosen market. In the absence of exacting and robustly enforced
    import requirements, the United States (U.S.) faces a real risk of
    receiving product deemed unsuitable for markets with more stringent
    controls.
               background on international food safety standards
        Article 20 of the General Agreement on Tariffs and Trade (GATT)
    allows governments to act on trade in order to protect human, animal or
    plant life or health, provided they do not discriminate or use this as
    disguised protectionism.
        The Agreement on the Application of Sanitary and Phytosanitary
    Measures (SPS) permits governments to set their own standards, but
    requires them to apply measures only to the extent required to protect
    human health. It does not permit Member Governments to discriminate by
    applying different requirements to different countries where the same
    or similar conditions prevail, unless there is sufficient scientific
    justification for doing so. It is indeed a basic precept of this
    agreement that there should be a sound scientific basis for food safety
    regulations. However, it does permit application of the precautionary
    principle when risks can not be quantified.
        The Agreement on Technical Barriers to Trade (TBT) seeks to ensure
    that technical regulations and standards and analytical procedures for
    assessing conformity with technical regulations and standards do not
    create unnecessary obstacles to trade.
        Both the SPS and TBT Agreements acknowledge the importance of
    harmonizing standards internationally to minimize or eliminate the risk
    of sanitary, phytosanitary and other technical standards becoming
    barriers to trade.
        The General Principles of the Codex Alimentarius states:

              The publication of the Codex Alimentarius is intended to
            guide and promote the elaboration and establishment of
            definitions and requirements for foods to assist in their
            harmonization and in doing so to facilitate international
            trade.
                  codex and the ethics of international trade
        Codex Alimentarius Commission also encourages food traders to adopt
    voluntarily ethical practices as an important way of protecting
    consumers' health and promoting fair practices in the food trade. To
    this end, the Commission has published the Code of Ethics for
    International Trade in Food. A principal objective of this code is to
    stop exporting countries and exporters from dumping poor-quality or
    unsafe food onto international markets.
                         national food safety standards
        Harmonization of food safety standards may indeed be a very worthy
    cause, however, it is generally accepted that Codex standards currently
    lack sufficient scope to be comprehensive. Neither does Codex address
    substances for which acceptable daily intakes (ADI) have not been
    established. These include (but are not limited to) residues of
    nitrofuran group of compounds and the antibiotic chloramphenicol.
    Disputes over the presence of these substances in food have caused the
    largest disruptions to international food trade, resulting from
    contamination, in recent years. As a consequence, many countries have
    developed a complete set of independent food safety regulations (albeit
    ensuring conformity with Codex standards whenever possible).
        Given the significant growth in global food trade in recent years,
    many countries are currently in the process of revising (or in many
    cases completely overhauling) their food safety legislation with regard
    to both domestic production and importation.
                           the european union system
        In 2002, the European Union made major changes to the way food
    safety legislation is developed and implemented, when it passed Council
    Regulation 178/2002 into European law. This regulation established The
    European Food Safety Authority, an independent body with responsibility
    for risk analysis, but devoid of risk management responsibility. This
    ensured that risks would be evaluated independently from the effect any
    legislation may have on trade, or on the management of the risk
    (testing). It also ensured that the requirements of the SPS agreement
    would be met in establishing a scientific basis for the legislation.
        This regulation also established the Rapid Alert System for Food
    and Feed (RASFF), whereby when violative food contaminants are detected
    either at market or at a Border Inspection Port (BIP) information
    relating to the product, the nature of the violation, the country of
    origin and the notifying country is published on a weekly basis, shared
    among the relevant competent authorities within the EU member states
    for action if necessary (recalls, increased vigilance, etc.) and
    simultaneously put into the public domain. Additionally, this
    legislation put in place an absolute requirement for traceability at
    all stages, from production, through processing, distribution and
    retailing.
        In the same year, legislation was introduced which specified the
    criteria which must be applied when validating the analytical
    techniques used for detection of chemical contaminants in food. The EU
    Commission has chosen not to prescribe analytical techniques, instead
    allowing regulatory laboratories to develop their own methods utilizing
    the latest advances and technological innovations to improve
    sensitivity, throughput and cost effectiveness. This is considered a
    significant factor in allowing laboratories in EU member states to
    respond rapidly to food safety issues and to keep pace with scientific
    advances. However, in Commission Decision 2002/657 validation criteria
    were laid down to ensure that laboratories demonstrate that analytical
    techniques are fit for purpose and suitably robust when detecting
    contaminants at the level of interest. The EU Commission demands that
    violative results be confirmed using an unequivocal, confirmatory
    technique and lays down the identification criteria that must be met in
    this decision. The use of a confirmatory technique is required to
    ensure that producers are not unfairly disadvantaged from the reporting
    of ``false positive results'' that can occur when screening tests are
    employed. This legislation also mandated that regulatory laboratories
    must be accredited under the international standard ISO 17025, ensuring
    that all laboratories are working to acceptable standards.
        The European Union ensures the safety of domestic food production
    through the implementation of a comprehensive raft of food safety
    legislation, regulating the use of veterinary drugs in product of
    animal origin (POAO) and of pesticides in both POAO and non-POAO.
    Compliance with this legislation is monitored through a comprehensive
    testing programme the level of testing of which is based on a
    percentage of annual production. These testing programmes are funded
    from a levy imposed on producers (for example, a levy per head of
    animals slaughtered in the case of POAO). The EU Commission has fixed
    the minimum levels of this levy depending on the species.
        It is noteworthy that for substances where the risk is established,
    but not quantified, the EU applies the precautionary principle. A
    significant number of contaminants are known to be carcinogenic and/or
    genotoxic, however the risk has not been quantified and they are seldom
    likely to generate acute conditions which can serve as signals of
    frequent violation. In these cases the EU has imposed a complete ban on
    their presence and requires laboratory analysis to demonstrate
    compliance.
                           how the eu treats imports
        Accepting that global trade in food is increasing year on year and
    that EU is probably the largest single market in the world, the EU
    Commission does not adopt the view that trading partners will
    automatically become food safety partners. Instead the EU makes the
    latter a precondition to becoming the former.
        The EU Commission maintains lists of approved countries and
    establishments within those countries, which are approved by
    commodities. Therefore, as an example, China must be named on an
    approved list for the export of seafood before any product will be
    permitted entry into the EU. Additionally, individual establishments
    within China are maintained on an approved list for the export of
    seafood and only those establishments are permitted to export product
    to EU. This system is similar to that operated by the USDA for meat and
    poultry, but in 2004 the EU extended this to make provision for not
    just POAO, but for any foods which may constitute a risk (Council
    Regulation 882/2004).
        A requirement for remaining on these lists includes the annual
    submission of details of control programmes which are in place
    regulating the safety of food produced for the EU including the results
    of regulatory monitoring. The underlying premise is that third
    countries must be able to offer assurances that food exported to EU is
    produced under a series of controls that offer at least the same
    guarantees of safety as is offered by European regulations. There must
    be a legal basis for enforcement of these regulations. Therefore,
    although the EU can not enforce its legislation on third countries, it
    does demand equivalence.
        An additional prerequisite for remaining on these approved lists
    involves permitting regular inspection of competent authorities,
    production, processing, traceability and the laboratories involved in
    regulatory monitoring (including checking the efficacy of methods of
    analysis employed). The aim of these inspections is verification of the
    assurances given and the inspections are carried out by the staff of
    the Food and Veterinary Office (FVO) with the assistance of scientific
    ``national experts.'' If a significant number of noncompliances are
    observed during an inspection mission, it can (and does) result in an
    establishment, or entire country being de-listed and therefore
    forfeiting the ability to export a given commodity to the EU.
        In 2001, a World Health Organisation (WHO) committee examining
    coordination and harmonization of food safety control systems concluded
    that whilst it is not possible to test our way to safe food, a robust
    monitoring system is vital to ensure compliance with regulation
    controlling food production. The EU Commission has determined that no
    consignment from a third country should be permitted to enter the EU
    without being subject to veterinary checks and that fixed percentages
    must undergo physical checks (Commission Decision 97/78). In practice,
    based upon assurances offered by third countries, a derogation
    regarding the level of these physical checks may be negotiated on a
    country-by-country basis.
        A mechanism for recovery of costs associated with carrying out the
    import monitoring has been described in Council Regulation 882/2004.
    This legislation lays down minimum charges per consignment that must be
    applied, but makes provision for recovery of the full economic cost of
    inspection and any laboratory analysis. The importer or their agent is
    responsible for these charges. A significant level of violation
    detected during this import monitoring may result in 100 percent of
    product undergoing laboratory analysis before it is permitted to enter
    the EU. If the violation is deemed to constitute a significant risk
    then it may result in the country being de-listed for that commodity.
                              the japanese system
        Japan is one of the least self-sufficient developed countries in
    the world, importing more than 60 percent of its food. Therefore, Japan
    has traditionally relied heavily upon the regulatory systems in the
    exporting countries for ensuring food safety. However, in 2002 a number
    of consumer organisations carried out surveys that found high
    concentrations of certain agricultural chemicals were present in
    imported crops. Many of the detected chemicals were banned from use in
    domestic Japanese production. This prompted a complete overhaul of the
    Food Safety Basic Law (the main statutory instrument regulating food
    safety in Japan). Central to this was the establishment of the Food
    Safety Commission, an independent body with responsibility for risk
    analysis. Additionally, the Specifications for Food and Food Additives
    was revised to include many more chemicals than had been previously
    addressed. This creation of the so-called Japanese Positive List
    (listing 799 agricultural chemicals) was prompted by the fact that the
    licensing of agricultural chemicals differs from one country to
    another. Prior to the creation of the positive list, when chemicals not
    licensed in Japan were identified in imported food, each violation was
    dealt with on a case-by-case basis. The maximum residue levels (MRLs)
    in the positive list are based on internationally accepted values where
    available, but a uniform limit of 10 parts per billion (ppb) is applied
    for substances for which safe levels had not been established.
        It is worth noting that Japan does not demand equivalence in terms
    of analytical testing, since domestic produce is not tested for the
    full range of chemicals detailed in the positive list, but accepts that
    local legislation effectively controls the use of unlicensed chemicals.
    In addition, the change in Japanese legislation did not make provision
    for maintenance of approved lists of countries and establishments, for
    the purposes of import. Instead, the onus for ensuring compliance was
    placed on the importer combined with heavy penalties for violation.
    When violations are detected, subsequent consignments must undergo
    voluntary testing in Japanese laboratories, paid for by the importer,
    before the consignment can be released. If the violation rate exceeds 5
    percent of consignments from an establishment (or country) then a
    complete ban on importation may result.
        For substances not permitted to be present at any concentration
    (so-called Not Detect or ND), the challenge is ensuring that all
    laboratories are capable of offering the same assurances. EU does this
    by specifying a minimum required performance level (MRPL) that
    laboratories must demonstrate. Japan has adopted a different approach
    in prescribing methods that must be used by Japanese regulatory
    laboratories. It appears to be generally accepted by the Japanese
    scientists that this author has spoken to, that this is too restrictive
    and limits the ability of the laboratories to employ recent
    technological advances, such as Ultra Performance Liquid Chromatography
    (UPLC, developed by Waters Corporation) to increase throughput and
    improve cost effectiveness.
        Although the Japanese government does not maintain approved lists
    for all commodities, when recurrent violations are detected, Japanese
    scientists may be dispatched to the offending country to offer
    technical assistance in a bid to correct the problem. The Japanese
    Government has subsequently introduced approved lists, but only for
    spinach imports. However, there is speculation that this may be
    extended to other foods.
                       differences between the eu, japan
        Whilst Japanese legislation appears similar to EU regulations,
    there are fundamental differences in the implementation. Whereas, EU
    demands equivalence in terms of legislation and levels of monitoring,
    Japan places the onus for compliance on the importer and ensures
    compliance through a very high level of import monitoring. The result
    is that Japanese importers will typically demand certification of
    compliance with Japanese regulations prior to dispatch.
        Despite this high level of testing of produce destined for Japan,
    the Japanese authorities ensure compliance by carrying out laboratory
    analysis for a very large number of contaminants at import (around 10
    percent of all imported food consignments undergo laboratory analysis)
    and publish the results of violations detected. It is interesting to
    note that a frequently used level of testing is designed to detect a 1
    percent violation rate with reasonable efficacy (that is to say, if 1
    consignment out of every 100 is violative for a particular substance
    then there is a 95 percent chance that violations will be detected),
    yet the dramatic changes in Japanese legislation were prompted by the
    discovery of a 0.4 percent violation rate across all commodities and
    chemical contaminants. It should also be noted that even a 10 percent
    inspection rate does not in itself constitute a significant level of
    protection. Rather, it serves as a monitoring tool to ensure
    compliance.
                           export food safety testing
        It might be reasonable to assume that such a high level of interest
    in food safety from a number of very large food importers would itself
    create a harmonized set of standards resulting in the food safety
    equivalent of ``herd immunity.'' In some instances, this may be the
    case. For example, the Thai Department of Fisheries has submitted a
    list of recommended establishments to the U.S. FDA which is very
    similar to the approved list maintained by the EU, but it is noted that
    use of these establishments by U.S. importers is voluntary and that
    some recent FDA refusals (October 2007) came from establishments not on
    the recommended list.
        It is also noted that whilst only 4 countries appear to have
    submitted lists of recommended establishments for seafood to the United
    States, 95 have done so to the EU (where it is mandatory). One assumes
    that this arises because the standards are not harmonized
    internationally and the requirements are very different from one market
    to another. Therefore, in practice, exporting countries tend to focus
    on separate schemes depending on the intended recipient. This is borne
    out by the observation that many establishments on the FDA refusals
    list are not on approved lists for the EU and therefore would not be
    permitted to export to the European Union. This should not be
    interpreted as an indication that they are necessarily producing
    substandard goods, but rather that they may be focused on markets not
    requiring advanced approval.
                                   conclusion
        It is clear that any food safety system which relies on voluntary
    compliance will be inherently risky, since even the very stringent
    systems employed by both the EU and Japan continue to give rise to a
    significant number of cases of violative food contamination (as
    published by each authority). Countries without unequivocal regulations
    governing the production of imported food run the risk of inviting the
    delivery of sub-standard products. This author has examined a seafood
    export action plan which clearly stated that seafood found to be in
    violation of EU regulations could be sold into markets where the
    regulations were less stringent. In the absence of comprehensive,
    internationally applied standards, imported food safety can only be
    ensured through the application of unambiguous legislation in
    combination with a robust enforcement and monitoring programme.

        The Chairman. Well, thank you very much. Tell me, Dr.
    Young, the point that I gather that you're making is that the
    food safety, certainly in the EU, I imagine in Japan as well,
    is more stringent, more restrictive than we have currently in
    the United States. Is that so?
        Mr. Young. It would be my opinion that the regulations in
    Japan and Europe are quite different but the one thing that
    they do share in common is a very strict enforcement and they
    are very well-
    defined. They have very well-defined standards. So the
    exporters are aware of the standards that they must meet.
        The Chairman. Well, if they do not meet the standards in
    terms of the EU, I think you mentioned that those food
    products, some of those can be sold to other countries?
        Mr. Young. The particular action plan that I was referring
    to was a document that I read a few years ago. And yes, it was
    clearly stated in the document that if food did not meet the EU
    standards then it could be sold into markets where the
    regulations were less stringent. And essentially what that
    means is that if their rules are not clearly stated that this
    is what we demand. This is the quality of product we demand.
    These are the standards that you must meet. Then essentially
    that product could be deemed to be compliant with those rules
    and regulations.
        The Chairman. Well, in a practical effect as some of that
    is sold in the United States. Is that correct?
        Mr. Young. I beg your pardon, sir?
        The Chairman. Some of those food products are sold in the
    United States. They don't meet the European standard and they
    can be sold here in the United States.
        Mr. Young. That could be the case.
        The Chairman. Well, is it the case? I mean you're an
    expert. I've got a limited period of time. It is the case,
    isn't it?
        Mr. Young. It probably is the case. I can't say for certain
    that those products were sold but one thing I can state is that
    products that are destined for Europe are tested before they're
    shipped to Europe. And I cannot say that the products destined
    for the United States undergo the same level of testing.
        The Chairman. Ms. DeWaal do you know that to be the case,
    or not?
        Ms. DeWaal. I think, Senator, that a number of States have
    actually proven this. They have tested seafood products that
    FDA is not testing and they have found illegal antibiotic
    residues. So in fact we think and FDA actually, after the
    melamine incident, FDA actually had to ban certain seafood
    products that, Senator, they had known for 7 years that these
    products were coming in with illegal pesticide residues. Excuse
    me, antibiotic residues. And they didn't ban them until after
    the melamine incident.
        The Chairman. You know, Mr. Taylor as I understand, the EU
    acted in 2002 to change the food safety system, establish the
    system that focuses on risk that provides for a rapid response
    when unsafe food is found. There is an absolute requirement to
    be able to trace all food to its source to retail and they have
    comprehensive testing on all foods. And countries that import
    to the EU must be pre-
    approved, on lists of approved countries, from approved
    suppliers in those countries, and even the foods are approved
    to import.
        Is that your understanding?
        Mr. Taylor. Yes, Mr. Chairman. I think the traceability
    requirement in particular illustrates a commitment----
        The Chairman. Do we have that type of system----
        Mr. Taylor. We do not.
        The Chairman [continuing]. Here in the United States?
        Mr. Taylor. Not implemented, that sort of farm-to-table
    traceability and accountability system here.
        The Chairman. And do you, just professionally, think that
    provides a greater degree of safety?
        Mr. Taylor. I think traceability, being able to know where
    a product came from and the conditions in which it was
    produced, from farm to table is fundamentally important.
        The Chairman. What about Japan?
        Mr. Taylor. Well, again, the Japanese as Mr. Young
    indicated have much more clearly defined standards for imports
    and higher degrees of inspection and testing than we do.
    There's no question about it.
        The Chairman. Don't you think a lot of Americans that might
    be watching this hearing could be saying, ``Well, why does
    Japan and why do the Europeans have stronger protective systems
    than the United States?''
        Mr. Taylor. I think it would be a fair question to ask. It
    is not as though we haven't known for a decade that our system
    can be improved in fundamental ways. GAO and the National
    Academy of Science have been telling us this for a decade. And
    so it is time to act to build this sort of systemwide
    prevention into our system.
        The Chairman. How much additional burden, Congressman
    Dooley, would this type of system put on the food industry?
        Mr. Dooley. Well, I think what we're suggesting, Senator
    Kennedy, is that we really have to define that public, private
    partnership that would be most effective in achieving that
    objective. And what we have proposed is that we would mandate
    that every importer on record, of every importer of food or
    food ingredient product in the United States would have to have
    a supplier quality assurance program. That would ensure that
    you would have in fact, the food safety audits that would be in
    place. That would ensure that those companies we're resourcing
    for have good management practices in place, sanitary practices
    in place. That we would develop these set of guidance with FDA,
    that you would then have the private sector being vested with a
    primary responsibility of preventing these occurrences.
        And one of the reasons why we think this is the most
    appropriate alternative is that we have 190,000 different
    companies that are registered under the Bioterrorism Act that
    would be eligible to import food products into the United
    States today. And we do not think that if you go down a
    regulatory approach where you'd have FDA vested with that
    responsibility that you're ever going to have that capacity and
    the resources to certify those.
        And so what we are suggesting is, we work in cooperation
    with FDA. That they help us set the standards and the guidance
    where the private sector then mandates to have the plans in
    place to ensure that we could have systems that would allow for
    greater traceability and greater confidence that we are having
    the food supplier require the audits are in place.
        The Chairman. Senator Enzi.
        Senator Enzi. Thank you Mr. Chairman.
        Dr. Young, you note that the European Union found that
    relying on voluntary compliance was insufficient and that you
    instead licensed other countries and individual foreign
    establishments. The FDA Food Protection Plan proposes third
    party certification but not country certification. And I'm
    thinking particularly of China where the compliance is so
    varied.
        You have some firms who definitely meet standards and
    others who have no intention of doing so. Could you elaborate a
    little bit on that role of certifying entire countries? Does
    that country certification have the unintended consequence of
    keeping good actors in non-certified counties from doing
    business in European Union, or in the United States.
        Mr. Young. Yes, Senator. You're quite right. The business
    of certifying countries in addition to certifying particular
    establishments from the European Union point of view is of
    vital importance. The reason for that is the European Union
    believes that compliance will not be achieved unless the
    government is involved, unless there is government regulation.
        I have acted as an EU inspector, involved in audits of
    third countries and the very first steps that are involved are
    inspecting the legislation to make sure that's there's a legal
    framework for taking action because the European Union believes
    that without that legal framework there will not be an
    effective system of control.
        Does that answer your question?
        Senator Enzi. That helps quite a bit. I'll have a follow up
    on that, probably in writing if you'd be so kind as to answer
    some more detailed questions that we don't have time to cover
    here.
        Mr. Dooley, requiring importers to ensure the safety of
    their supply chains does make a lot of sense to me. And your
    larger members can easily travel to other countries and inspect
    the factories or have a long-term presence in those facilities.
    Big companies can have staff that are dedicated to those
    issues. What would a small business do?
        Mr. Dooley. Well we think it's important that whether it's
    a small company or a large company that is engaged in
    international commerce and is sourcing products from outside
    the United States that they also have a responsibility to
    comply with putting in place the best practices which are going
    to ensure that we are mitigating and preventing food safety
    outbreaks. You know, you see today a lot of small and mid-size
    companies are resourcing products. They have the ability to
    contract with intermediaries that can, in fact, provide some of
    the food safety quality audits that would need to be put in
    place that have the contractual arrangements that would allow
    them to also comply with this suggestion that we are making
    that you have a mandatory supplier quality audit in place if
    you're going to be importing a product into the United States.
        And if I could just briefly make one comment on your prior
    question on this whole issue of certification and equivalency,
    in theory that sounds like a very sound and fairly reasonable
    and simple approach. But I just want to caution people. We have
    been trying to negotiate with Canada an equivalency agreement
    on fish processing that they have similar standards in place
    that would meet ours. We have been trying to do that for 10
    years and we have not been able to achieve that with Canada
    alone which would be a similar industrialized country as the
    United States.
        So I think we have to be very cautious about going down a
    path in terms of thinking that this equivalency and the
    certification of a country and their standards being similar to
    ours is going to be easily obtained.
        Senator Enzi. Thank you. And I'll have some follow up
    questions on that as well in writing.
        Mr. Corby, why do you think you're able to detect problems
    at a much higher rate than the FDA or the USDA?
        Mr. Corby. Well, for one thing I think because of our
    resources. And we have quite a few inspectors. And we do a
    great deal of surveillance. And we do a great number of
    inspections.
        Plus we're closer to the consumer in that we do the retail
    inspections, the restaurants, the grocery stores and we're the
    first ones to be contacted when there's an illness. So I think
    it's because we're alert of these problems probably firsthand.
        Senator Enzi. Thank you. And again I'll have some follow up
    questions on that and some for Ms. DeWaal as well, but since
    your voice is going I'll let you do that in writing.
        The Chairman. Thank you.
        Senator Allard.
        Senator Allard. Thank you Mr. Chairman. I'd like to start
    out with Dr. Young. We have different problems in, I mean, your
    uniformity issues that you're talking about in certification
    and assessment in different countries and in different
    companies, there's a lot of difference depending on what part
    of the world you're in and diseases that you might be dealing
    with that could affect the food supply.
        How does a country like England for example or Ireland, set
    up a uniform assistance of assessing that or do you get very
    specific for each country and you look at those diseases from
    that country and you set up regulation just for that country or
    do you have a general set of rules? And then if you do this how
    do you reconcile that with trade agreements between the various
    countries?
        Mr. Young. Senator, the first thing I have to say is that
    my area of expertise is chemical contaminates, not microbial
    contamination and the way that the EU handles that level of
    chemical contaminate control is through a uniform set of
    conditions. The EU will draft legislation which can be based
    either as a regulation which does not need to be transposed
    into domestic law or it can set up these commission decisions
    which do need to be transposed.
        So when the EU deems that it's important and it's important
    that everyone works to the same standards they will draft a
    regulation and that's of course across the entire European
    community. And those regulations then need to be also
    transposed into the domestic law of the exporting countries to
    ensure that the standards are the same. This is all with regard
    to chemical contaminates. And that includes not only the range
    of contaminates that need to be monitored which will be
    adjusted based on the commodity on a risk-based analysis but
    also includes things like the level of testing, the level of
    monitoring that need to be carried out to ensure that there is
    compliance with the local regulations.
        Senator Allard. We have certain countries that recognize
    products as being hazardous and other ones don't, based on good
    scientific knowledge. For example, in Colorado or in the United
    States, the scientific literature and what we generally
    recognize here is that certain hormones to stimulate growth
    development in cattle are not harmful. Yet there are European
    countries, or Europe, I think, recognizes those as harmful.
        How do you reconcile that and the scientific literature
    indicates, in the United States, that it's not harmful and in a
    European country they apparently feel it is or is it purely a
    trade issue?
        [Laughter.]
        Mr. Young. That's a very difficult question to answer, sir.
    Is it a trade issue? Perhaps there's an element of trade
    associated with it, but, the argument I believe the European
    Union takes on that particular subject is that they adopt a
    precautionary principle. And that's to say that they are not
    sure whether the science is verified and therefore they will
    adopt a precautionary approach. And they will therefore ban
    those substances.
        Senator Allard. So the World Trade Organization in these
    trade agreements allow you to take a precautionary approach so
    that if anybody makes an allegation as far as you're concerned
    from a protectoral standpoint whether you can prove that it's
    safe or not then you apply that standard just on the allegation
    itself whether you have the scientific body to support the rule
    or regulation.
        Mr. Young. Well certainly the Sanity and Phytosanitary
    agreement make provisions for the precautionary principle. I
    still believe that there's a need to prove that there's a
    reasonable basis for those precautions and whether or not
    Europe has done that with regards to hormones I'm not sure.
        Senator Allard. Thank you. Mr. Coby. Is it Coby?
        Mr. Corby. Corby.
        Senator Allard. Yes, Corby.
        Mr. Corby. Yup.
        Senator Allard. In the State of New York you have authority
    to shut down a business if it creates a public health problem,
    don't you?
        Mr. Corby. Yes, we do.
        Senator Allard. Yes. I think that's true in most States,
    isn't it?
        Mr. Corby. Yes, it is. Most all of the establishments are
    either licensed or permitted by State or locals.
        Senator Allard. Right.
        Mr. Corby. And we can revoke the license, yes.
        Senator Allard. You----
        Mr. Corby. And we also have the seizure authority which
    allows us to stop a product that we believe may be adulterated
    in its track.
        Senator Allard [continuing]. You have inspected grocery
    stores I assume?
        Mr. Corby. Yes.
        Senator Allard. Have you ever looked at the bulletin board
    on a grocery store? I have, at least in Colorado. They'll have
    a bulletin board up there that's maybe 2 feet square or 2  3
    and it's plastered with permits and----
        Mr. Corby. Oh, yes.
        Senator Allard [continuing]. All sorts of licenses and what
    not.
        Mr. Corby. Yes.
        Senator Allard. And you wonder how in the world they can
    comply with all that, don't you from time to time?
        Mr. Corby. Yes.
        Senator Allard. They do. But, I think we need to be careful
    on how much we force on a small business like that, you going
    to do that inspection.
        Mr. Corby. Well, there's a lot of things going on at the
    State and local level where they now will post inspection
    reports on a Web site or are required to post it at the front
    door.
        Senator Allard. Yes. And so it quickly becomes available
    to----
        Mr. Corby. Yes.
        Senator Allard [continuing]. The public if they're
    interested in one. And they'll do an evaluation on the store
    and how they're doing. And those reports are all made public I
    assume.
        Mr. Corby. Yes, they are.
        Senator Allard. So they really have strong enforcement----
        Mr. Corby. We do.
        Senator Allard [continuing]. Rules as far as that's
    concerned, yes.
        Mr. Chairman, thank you.
        The Chairman. Thank you very much. We'll submit to leave
    the record open and submit some questions.
        I think it's been an enormously interesting and valuable
    hearing today. We've had a good explanation on the issues of
    food safety today.
        The Advisory committee report is a clear call for action
    and our committee is determined to answer that call. I look
    forward to working with all of our colleagues to see that we
    develop a comprehensive approach to the challenges that the FDA
    faces both in food safety and in these other areas. This has
    been very, very valuable, very useful and we are very grateful
    to all of our witnesses and we will be submitting that we leave
    the record open for a week. We're going to be submitting some
    additional questions and calling upon you as we try to fashion
    and shape a legislative approach to ensure greater protection
    for American families.
        Thank you very, very much. And the committee stands in
    recess.
        [Additional material follows.]

                              ADDITIONAL MATERIAL

          Prepared Statement of Safe Food International--World Health
                                  Organization
                                    preamble
        Foodbome illnesses are prevalent in all parts of the world,
    resulting in millions of deaths each year. In developed countries, such
    as Australia and the United States, about one in three persons
    experience some type of foodborne illness every year, which can range
    from mild to fatal. In the developing world, the World Health
    Organization (WHO) estimates that contaminated food contributes to 1.5
    billion annual episodes of diarrhea in children below the age of five
    and at least 1.8 million deaths. Food also can carry traces of
    hazardous chemicals, like pesticides or heavy metals, that cause
    neurological and hormonal damage as well as cancer. From production to
    consumption, it is the responsibility of national governments, the food
    industry, and consumers themselves to ensure that food is safe.
    However, governments have the pivotal role of providing a framework for
    establishing effective food safety programs.
            united nations food safety resolutions and other actions
        While the need to ensure safe food was recognized when WHO was
    established more than 50 years ago, more recently the International
    Conference on Nutrition (Rome, 1992)--cosponsored by WHO and the Food
    and Agriculture Organization of the United Nations (FAO)--declared that
    access to nutritionally adequate and safe food is an individual right
    of all consumers. They specifically urged governments to ``establish
    measures to protect the consumer from unsafe, low quality, adulterated,
    misbranded, or contaminated foods.''
        In 1993, the FAO held a Technical Consultation on the Integration
    of Consumer Interest in Food Control. The consultation, with inputs
    from organizations representing consumers' interests, identified the
    following issues as critical consumer concerns: nutritional quality;
    safety standards; labeling; environmental contaminants; food
    irradiation; and the application of modern biotechnology to food
    production and processing. It also identified barriers to consumer
    input in food control, particularly in developing countries.
        The 53rd WHO World Health Assembly (Geneva, 2000) adopted a food
    safety resolution calling on its 192 Member States: ``to integrate food
    safety as one of their essential public health and public nutrition
    functions and to provide adequate resources to establish and strengthen
    their food safety programs in close collaboration with their applied
    nutrition and epidemiological surveillance programs.'' The WHO World
    Health Assembly in a separate resolution adopted in 2002 also
    recognized the urgent need to protect food from threats of intentional
    contamination with biological and chemical agents and radiological
    materials.
        In 2002, the United Nations in cooperation with consumer
    organizations drafted and eventually adopted guidelines for consumer
    protection that urges governments to ``give priority to areas of
    essential concern for the health of the consumer, such as food, water,
    and pharmaceuticals. . . . Governments should maintain, develop or
    improve food safety measures, including, inter alia, safety criteria,
    food standards and dietary requirements and effective monitoring,
    inspection and evaluation mechanisms.''
        These international resolutions attest to the growing urgency of
    food safety. As food is increasingly traded globally, food safety has
    become a global public health issue. Dialogue between the United
    Nations' specialized agencies and groups representing consumers'
    interests is vital to improving national programs and protecting all
    consumers. Valuable contributions have been made by the long-standing
    involvement of international consumer organizations like Consumers
    International and the growing involvement of the International
    Association of Consumer Food Organizations in the work of the Codex
    Alimentarius Commission and its subsidiary bodies that deal with health
    and safety issues.
                      formation of safe food international
        In 2003, the Center for Science in the Public Interest (CSPI) *
    started the Safe Food International project with support from the WHO,
    FAO, and consumer organizations in many parts of the world to promote
    stronger national food safety programs, to reduce food-related deaths
    and illness, and to deter the use of food as a target of intentional
    contamination.
    ---------------------------------------------------------------------------
        * CSPI represents over 900,000 consumers in the United States and
    Canada and was also the founding organization for the International
    Association of Consumer Food Organizations.
    ---------------------------------------------------------------------------
        Safe Food International was established on the principle that,
    while food-safety hazards vary from region to region, consumers in all
    parts of the world are critically concerned about the safety of the
    food they eat. As food production changes from local systems to
    international ones, consumers are demanding that food safety programs
    at home and abroad ensure that the food marketed to their families is
    safe to eat. National food-safety programs are usually funded by taxes
    paid by consumers, who depend on those programs to protect their
    health. However, in most countries, consumer and non-governmental
    public-health organizations have no formal role in the development of
    food-safety policies.
        Consumer organizations can be instrumental in promoting effective
    national food safety systems. Encouraging greater coordination among
    interested groups, allocating additional resources to consumer
    representation, and providing more opportunities for consumer
    participation would be beneficial in many countries.
                         development of the guidelines
        Safe Food International developed these Guidelines in
    consultation with consumer organizations in both developed and
    developing countries, based on WHO and FAO reports describing the
    elements of effective national food safety programs and CSPI's
    experience as a leading food safety advocate. Consumer organizations
    and national governments can use these Guidelines to strengthen their
    national food-safety programs and guard against any potential hazards
    in the food supply, including intentional contamination (food
    bioterrorism). Ultimately, the Safe Food International Guidelines
    assist both consumer organizations and governments in focusing on the
    basic requirements for national food safety programs in their
    countries.
    ---------------------------------------------------------------------------
         These Guidelines may be translated, quoted, and reproduced
    by bona fide consumer organizations to promote the development of sound
    national food safety programs. Reference to Safe Food International
    would be appreciated. For further information, please contact Safe Food
    International, 1875 Connecticut Avenue, NW, Suite 300, Washington, DC.
    20009, (202) 777-8364, or by email at sfi@cspinet.org. To find the
    Guidelines and other related materials, please see the Safe Food
    International Web site, at www.safefoodinternational.org.
    ---------------------------------------------------------------------------
        With the cosponsorship of WHO and FAO, Safe Food International has
    convened an international conference that developed these Guidelines in
    consultation with the following consumer organizations: Union for the
    Protection of Consumer Rights (Armenia); Test-Achats (Belgium); Ligue
    pour la Defense du Consommateur (Benin); ProTeste (Brazil); Federation
    of Consumers in Bulgaria; Mouvement National des Consommateurs
    (Cameroon); Center for Science in the Public Interest (U.S. and
    Canada); Ontario Public Health Association (Canada); Union des
    Consommateurs (Canada); Organizacion de Consumidores y Usuarios
    (Chile); Pesticide Eco-Alternatives Center (China); EcoWomen (China);
    China Consumers' Association; Estonian Consumers Association;
    Federation of Consumer Organizations (India); Consumer Coordination
    Council (India); Voluntary Organization in the Interest of Consumer
    Education (India); Consumers Korea (Republic of Korea); Consumers
    Lebanon; Consumers Association of Penang (Malaysia); Pro Public
    (Nepal); Consumers' Institute (New Zealand); Asociacion Peruana de
    Consumidores y Usuarios (Peru); Polish Consumer Association;
    Association Senegalaise pour la Defense de 1'Environnement et des
    Consommateurs (Senegal); National Consumer Forum (Seychelles);
    Consumers Union (United States); Consumer Education Trust (Uganda);
    Which? (United Kingdom); Centro de Estudios, Analisis y Documentacion
    del Uruguay (Uruguay); Consumidores y Usuarios Asociados (Uruguay);
    International Association of Consumer Food Organizations; Consumers
    International.
        Financial support for Safe Food International was provided by the
    NTI Foundation's Global Health and Security Initiative; the Center for
    Animal Health and Food Safety; the Philancon Fund; and the Center for
    Communications, Health and the Environment. The Canadian International
    Development Agency and the FAO provided travel funding to conference
    delegates from developing countries.
               Guidelines to Promote National Food Safety Systems
        The Guidelines cover eight essential elements for an effective food
    safety program: Food Laws and Regulations; Foodborne Disease
    Surveillance and Investigation Systems; Food Control Management;
    Inspection Services; Recall and Tracking Systems; Food Monitoring
    Laboratories; Information, Education, Communication, and Training;
    Funding and Affordability of the National Food Safety Program.
                          1. food laws and regulations
        Each country must have effective, comprehensive food legislation to
    give its government the authority to ensure a safe food supply. Some
    countries have not developed specific laws to assure food safety--or
    they have developed such laws only recently. In other countries, food
    safety laws were drafted decades ago. Frequently, they do not address
    emerging hazards, like harmful bacteria, viruses, mycotoxins,
    pesticides, and prions, or new innovations, such as genetically
    modified plants and irradiation. Consumer organizations should be
    vigilant in identifying ways in which their national laws should be
    implemented, strengthened and modernized.
        A modern national food law contains several essential elements.
    First, it should provide a framework for an integrated and coordinated
    food safety system. It should give food safety authorities effective
    tools to respond promptly to hazards in the food supply, especially
    during emergencies, and to remove hazardous food from the market in a
    timely fashion. Finally, it should promote the use of preventative food
    safety systems.
        Food safety legislation should:

         Be developed with the participation of all stakeholders,
    and in particular consumer organizations.
         Articulate a high level of health protection, for example,
    food should be ``safe for human consumption.''
         Contain clear definitions to increase consistency and
    legal security.
         Be based on scientific advice that is high quality,
    transparent, independent, and at a minimum, in line with standards,
    guidelines and other recommendations of the Codex Alimentarius
    Commission.
         Ensure the food authority and food producers and
    processors give consumers accurate information about food products,
    including labeling on all matters relevant to their health and safety.=
    ---------------------------------------------------------------------------
        = Governments should follow appropriate Codex guidelines for the
    use of Halal claims in food labeling.
    ---------------------------------------------------------------------------
         Include mechanisms to facilitate traceback and recall of
    contaminated food.
         Put primary responsibility for producing safe food on
    producers and processors.
         Be regularly monitored and evaluated to ensure all
    stakeholders' requirements are being met.
         Apply to food aid, including during times of food security
    emergencies.

        National legislation should require establishment of standards or
    other relevant management options for disease-causing organisms;
    naturally occurring contaminants such as aflatoxin; pesticide residues;
    and environmental contaminants, such as lead and methylmercury. It
    should enable monitoring and enforcement of these standards effectively
    and efficiently. The aim of such management options should generally be
    a continuous improvement of the national food safety situation.
        Legislation should also establish requirements for labeling
    relevant to food safety and risk management addressing issues such as:
    ingredients in descending order by weight; presence of allergens; date
    marking; and instructions for safe use and storage. The labeling of
    food produced by genetically modified organisms is currently being
    discussed by the Codex Committee on Food Labeling.
        All substances intentionally added to food and all new food
    technologies that may change the safety or nutritional qualities of
    food should be shown to be safe and suitable for their intended
    purposes. Food legislation should establish pre-market approval
    procedures for food additives, artificial food components and
    ingredients, foods derived from modern biotechnology, food processing
    technologies such as irradiation, and residues of food animal drugs and
    pesticides to ensure safety and nutritional adequacy of the food supply
    for consumers. These procedures should establish the safe conditions of
    use through labeling instructions and maximum residue limits or maximum
    levels.
        Food legislation should require that feed for food-producing
    animals, including feed additives, and drugs for food-producing animals
    are safe for both humans and animals, including possible antimicrobial
    resistance. Feed for ruminants (cows, sheep, goats and others) grown
    for food should not contain ruminant tissues or by-products.
          2. foodborne disease surveillance and investigation systems
        A foodborne-disease surveillance system tracks information on
    illnesses, gathers information to identify outbreaks (two or more
    illnesses linked to a single hazard), links outbreaks to food sources,
    and traces the food identified in the outbreak back to its origins.
        The first evidence of contamination of food will likely be found
    through the surveillance system. An effective surveillance system is
    one that identifies foodborne-illness outbreaks while there is still
    time to remove the contaminated food from the market and prevent
    illnesses. This is especially true for incidents involving food that
    has been intentionally contaminated.
        Many countries have surveillance systems that rely on
    investigations of illnesses that are reported to medical officials. In
    some countries, sophisticated surveillance systems are designed to
    deliver a high degree of certainty before specific foods are linked to
    an outbreak. Such food attribution information is important to both
    risk managers and the public. However, some countries use systems that
    were developed to address food industry concerns that the wrong food
    might be blamed for causing a food-borne illness outbreak. Those
    systems can be too slow to operate effectively in an emergency.
        To help risk managers issue more timely food recalls and to address
    the threat of intentional contamination, countries should review their
    surveillance systems with respect to their capacity to recognize
    emergencies rapidly.

        1. A national food control system should establish links between
    the symptomatic foodborne-illness surveillance system and the food-
    monitoring system (see section 6 below).
        2. Countries should establish or strengthen early warning systems
    to allow rapid detection of contamination incidents to ensure prompt
    public alerts.
        3. Countries should ensure that their surveillance systems include
    data on the symptoms and effects of chronic exposure to foodborne
    contamination.
        4. Identifying diseases in animals may provide a quicker indication
    of a problem in the food supply than waiting for human diseases to
    occur. Linking the veterinary health sector to the surveillance network
    might provide earlier warning of a problem in the food supply.

        The public should have the right to information emerging from the
    surveillance systems, including all data to support:

         Annual foodborne disease incidence trends.
         Identification of susceptible population groups.
         Identification of hazardous foods.
         Results of routine sampling and analysis of food products.
         Identification and tracing of causes of foodborne disease
    from the farm to the kitchen.
         Early alerts for outbreaks and food contamination.
                           3. food control management
        Many countries currently have more than one food safety agency,
    some with conflicting or overlapping responsibilities. An integrated
    national food control authority should address the entire food chain
    from farm-to-table and should have the mandate to move resources to
    high-priority areas.
        The national legislation should define the food-control management
    structure. Core responsibilities of that system include establishing
    regulatory measures, monitoring system performance, facilitating
    continuous improvement, and providing overall guidance.
        National legislation should define an integrated or coherent food
    safety system including designation of a lead food safety authority
    that should be empowered to:

         Develop and implement an integrated national food-control
    strategy.
         Set standards and regulations.
         Approve new food ingredients and food safety technologies.
         Participate in international food-control activities.
         Develop emergency response activities.
         Carry out risk analysis.
         Monitor enforcement activity and performance.
         Implement effective mechanisms for involving stakeholders,
    including Consumer organizations, at different steps of the
    decisionmaking process.
         Develop and promote food safety training curricula and
    programs.

        Sufficient resources should be provided to the authority to carry
    out its mandate.
        Risk analysis plays an important role for a national food control
    system. Risk analysis comprises of three stages: risk assessment, risk
    management and risk communication. Risk analysis involves identifying
    risks, weighing their likelihood and their impact, and establishing
    systems to manage and minimize risks. Risk management is the term given
    to the legal, regulatory, educational, and voluntary actions used to
    control risks. Risk assessment is a scientifically based process
    consisting of the following steps: Hazard identification, hazard
    characterization, exposure assessment, and risk characterization. Risk
    assessment should always be carried out openly and transparently and
    ideally by independent scientific committees which are open to public
    scrutiny. While formal risk assessments can be highly beneficial, they
    can also be very time-consuming and expensive, beyond the reach of many
    governments. It is also essential that risk assessments answer the
    right questions and are explicit about any judgments or assumptions
    that have been made.
        Where the science is uncertain or inconclusive, but there is
    evidence of a potential risk, it is important that a precautionary
    approach is adopted by risk managers. Failure to take action
    sufficiently early to protect the public can have devastating
    consequences.
        Risk assessment is therefore an important aspect of risk management
    decisions, but not the only one. Other factors may also need to be
    taken into account by risk managers when determining the approach that
    has to be taken. Public involvement throughout the risk analysis
    process is essential in order to understand what these broader factors
    may be (including for example ethical, environmental or broader social
    aspects) which can affect people's willingness to accept a particular
    risk. It is essential that consumers are involved in determining an
    acceptable level of risk.
        Risk communication is essential and has to be a two-way process
    between risk managers, risk assessors, consumers and their
    representatives, and other stakeholders.
        Risk-management decisions should be based on the best available
    evidence and proceed within a timeframe that can minimize consumer
    harm. Risk managers can be informed by risk assessments conducted
    either in their own country or assessments done for international
    organizations, like the WHO. In order to respond to food safety
    emergencies, the government should establish a national food safety
    emergency coordination body. An effective emergency response system
    must be tailored to the circumstances and should include links to law
    enforcement and intelligence agencies, food-recall systems, risk
    assessment specialists, and the food industry, as well as the more
    traditional sectors of health care providers, laboratories, and
    emergency services. These systems should be tested to ensure that the
    communication and response systems work effectively.
                             4. inspection services
        Sound food safety legislation and policies are meaningless unless
    they are effectively enforced. Inspection services form the core of the
    food safety system, giving government regulators, customers, and
    consumers regular information regarding conditions throughout the food
    chain and on farms that can impact the safety of the food supply. In
    addition, inspectors give the government in-house expertise that can be
    used to conduct investigations and respond to food safety emergencies.
        Food premises should be inspected as a matter of principle before
    they sell to the public to ensure that they meet hygiene requirements.
    Food inspection must ensure that all foods are produced, handled,
    processed, packed, stored, and distributed in compliance with
    legislation and regulations. Food inspection and regulation should
    extend from the farm to restaurants, street vendors, and other retail
    venues. There should be a sufficient number of inspectors to allow an
    adequate frequency of inspections. These inspections should be based on
    the risks posed by different foods and the history of problems in a
    particular sector of the food supply.
        The food inspector is a key functionary who has day-to-day contact
    with the food industry, trade groups, and often the public. The
    inspector must therefore be honest and well-trained, independent, and
    be in a position to avoid external influence, including potential
    conflicts of interests. Training of food inspectors is an important
    component of an efficient food-control system. As national programs
    improve with the introduction of systems focused on controlling and
    preventing food safety problems (so-called Hazard Analysis and Critical
    Control Point (HACCP) systems) and the adoption of new technologies to
    improve food safety, retraining should be conducted to ensure that
    inspectors are providing optimal services.
        Traditional inspection functions include responding to non-
    compliance with food laws, handling consumer complaints, and advising
    the food sector. In a modern food safety system, inspection functions
    include the following:

         Inspecting premises and processes.
         Evaluating HACCP plans.
         Sampling food during harvest, processing, storage,
    transport, or sale.
         Recognizing spoiled and hazardous food, food that is
    otherwise unfit for human consumption, or food that is deceptively sold
    to consumers.
         Recognizing, collecting, and transmitting evidence.
         Encouraging the use of voluntary quality assurance
    systems.
         Conducting inspection, sampling, and certification of food
    for import/export purposes.
         Conducting risk-based audits of food establishments with
    HACCP or other safety assurance programs.
         Recommending formal action, including prosecution, where
    food safety lapses could endanger public health.

        Information on food inspection results, such as hygiene scores,
    should be made available to the public through, for example, web-based
    systems, media and other communication channels.
                         5. recall and tracking systems
        Recall and tracking systems are vital to consumers and other actors
    throughout the food chain when food that does not comply with national
    standards, including contaminated food, inadvertently reaches any part
    of the food chain, including the consumer. The national food safety
    system should have comprehensive procedures covering the prompt removal
    of contaminated and mislabeled food products from the domestic market.
    Recalled products that are deemed to be unsafe should be properly
    disposed of and not exported to other countries.
        Recalling contaminated food can be triggered by the food industry,
    consumer organizations, or the food control authorities. Tracking
    systems are used to trace the route of contaminated food or sick
    animals that may enter the food supply. Outbreak investigations often
    use tracking systems to trace back food linked to an outbreak to the
    farm or factory that produced it.
        Tracking or traceback systems may also be required in order to give
    additional reassurances of safety, for example, to enable post-market
    monitoring of any unintended health effect. They are also important to
    ensure liability and compensation.
        Tracking systems generally start with the food producers. In the
    case of live animals, it may include animal identification systems
    using ear tags and other devices. Processed foods should be clearly
    marked with a lot number and the time and date of production. Produce,
    grains and other plant-based foods should be labeled in a manner that
    clearly indicates the place of origin (country and State or province
    and preferably the farm or packing house). In all cases, packaged food
    purchased by the consumer should be marked to allow identification.
        Recall systems should be a coordinated effort between the national
    government and the individual firm(s). If the government requests a
    recall, firms should have an affirmative duty to recover recalled
    products and to destroy or dispose of them properly. National laws
    should include penalties for companies that fail to comply with recall
    requests from national governments.
                        6. food monitoring laboratories
        Laboratories are an essential component of an effective food
    control system. They allow regulators, producers, and consumers to
    examine food for chemical and microbiological hazards that are not
    apparent through routine physical examination. Laboratory analysis can
    be critical to:

         Identifying contaminated foods.
         Identifying the source of an outbreak of food poisoning.
         Allowing regulators to bring enforcement action against
    adulterated and unsafe food.
         Confirming the safety of domestic food products as well as
    exports and imports.
         Allowing for dietary exposure assessments.
         Allowing consumer organizations and food processors to
    monitor and analyze the food quality at the user end.
         Assist in the regulatory decisionmaking process and
    evaluate the effectiveness of risk management interventions.

        Effective food-control programs are able to monitor the quality and
    safety of the Nation's food supply. It is government's responsibility
    to ensure that mechanisms are put in place to make sure food is safe
    before it is marketed. A range of analytical capabilities are required
    for detecting a large variety of food contaminants, such as pesticides,
    pathogenic bacteria, pathogenic prions, foodborne viruses, parasites,
    radionuclides, environmental chemicals, and biotoxins. In addition,
    capabilities to test for spoilage and compliance with all other
    official food-control standards are needed.
        The food-control management authority should establish quality
    assurance (proficiency) criteria for the operation of laboratories and
    should monitor their performance.
             7. information, education, communication, and training
        Communication among food safety, agriculture and other relevant
    authorities, consumers and consumer organizations, and the food
    industry should be a vital and continuous function of a national food
    safety program. Communication with the public and the food industry in
    emergency situations, such as disease outbreaks or contaminated food
    alerts, is an increasingly important component of the national food
    safety system. Consumers should always be promptly, accurately and
    fully informed about any disease outbreak, contaminated food incident,
    or food recall through a sound alert system and traceability using
    effective and practical communication methods. Communication must be a
    two-way process to ensure that authorities are aware of and take
    account of consumer concerns and perceptions.
        Wherever possible, risks should be explained in the context of the
    overall diet. Where it is not possible to give consumers clear
    information or advice about a risk, efforts should be made to explain
    as clearly as possible what is and is not known and what steps are
    being taken to address uncertainties.
        Informing the public and the food industry about trends in food and
    foodborne diseases is an important role of government authorities.
    National governments should ensure communication during emergency
    situations by establishing industry alert and agriculture alert
    systems. Through the network of food safety regulators (INFOSAN), WHO,
    and in cooperation with FAO, operates an electronic information system
    to keep regulators informed of the emerging food safety issues,
    including emergency situations.
        Giving consumers' advice regarding how to avoid foodborne illness
    is an educational function of the national food safety program.
    Education programs should begin in childhood using both formal and
    informal methods. Programs should also target high-risk groups and/or
    their caregivers. High-risk consumers include infants and young
    children, pregnant women, the elderly and immune-compromised
    individuals.
        On-going training in specific skills, such as communication, and
    technical capacity building for inspectors, laboratory personnel,
    scientists, consumer organizations, and the food industry is critical
    to ensure that existing inspection programs are prepared to handle
    emerging hazards and to integrate new technologies to reduce hazards.
       8. funding and affordability of the national food safety programs
        National food safety programs must be funded sufficiently and
    transparently to conduct regular inspections of food-processing
    facilities and imports, to conduct laboratory tests of both domestic
    and imported food, to set standards and do risk analysis, as well as
    many other functions. The nature of the funding must not compromise
    their integrity and independence. Funds must be utilized efficiently to
    maximize public health protection and with accountability to the
    public.
        Governments have the primary responsibility for ensuring the safety
    of domestic, imported, and exported food, and should provide core
    funding for such activities. However, support for building the
    capacities of such systems in the poorest countries should be the focus
    of bilateral and multilateral assistance, as appropriate.
        Many countries fund food safety programs using cost-recovery
    systems. Cost-
    recovery options include a tax and/or specific fees for licensing,
    inspection activity, food sampling and analysis, and food safety
    training. However, those systems should not unfairly impact the poorest
    consumers and public health organizations.
        Food safety programs must be structured to protect and promote
    public health and be affordable and accessible to small farmers and
    producers. This is important for preserving the diversity and quality
    of the food supply. Costly regulatory measures can put small farmers
    and producers out of business. Consolidation of the food industry can
    make food more vulnerable to large-scale contamination.
    Response to Questions of Senators Kennedy, Harkin, Mikulski, Bingaman,
                 Brown, Enzi, Burr and Hatch by Michael Levitt
                          questions of senator kennedy
        Question 1. There's a lot of real value in the Food Protection
    Plan. One thing that concerns me, however, is that the plan proposes
    allowing the agency to require process controls for a food, but only
    after the food is associated with repeated instances of serious adverse
    health consequences or death. Why should the FDA have to wait for
    children or the elderly to die or be seriously injured by a food before
    companies making it are required to make it safely?
        Answer 1. An overarching strategy of the Import Safety Action Plan
    and the Food Protection Plan is to target Agency resources to achieve
    maximum risk reduction. FDA will primarily focus on promoting the use
    of risk-based, preventive systems that companies can voluntarily apply
    at all levels of food production and processing, when appropriate.
        Potentially high-hazard food categories may require additional
    control measures. To address the potential need for additional control
    measures for high-hazard food categories, HHS has requested explicit
    authority to issue regulations requiring specific types of foods
    (associated with repeated instances of serious health problems or death
    to humans or animals from unintentional contamination) be prepared,
    packed, and held under a system of preventive food safety controls.
    Such authority would strengthen the FDA's ability to require
    manufacturers to implement risk-based HACCP or equivalent processes to
    reduce foodborne illness from high-risk foods. The criteria that the
    food be ``associated with repeated instances of serious health problems
    or death to humans or animals for unintentional contamination''
    provides a clear and straightforward definition of high-risk foods or
    categories of food of greatest Agency concern. The identification of
    high-risk foods eligible for this provision can be made based on
    existing data and knowledge so FDA would not have to wait for further
    deaths or serious injury before these provisions could be implemented.
    By targeting recognized high-risk foods, but not limiting the overall
    preventative approaches to high-risk foods, we hope to achieve the
    greatest public health impact with the resources available.

        Question 2. One recommendation in the Plan is that FDA should
    certify third parties to conduct food safety inspections. There may be
    real value in such a program, but we authorized such a program for
    medical devices in 2002 and very few device companies have taken
    advantage of it. What do you think will make food companies participate
    in a third party inspection program? What sort of resources will the
    FDA need to review and act on all the information that these
    inspections might generate?
        Answer 2. One lesson learned from our experience with other third
    party inspection programs is that industry participation depends on
    appropriate incentives. Accordingly, we intend to seek input from
    stakeholders to best understand how to maximize participation in a
    third party inspection program for food. This will assist in estimating
    the resource requirements to review and act on the information that may
    flow from third party inspections.

        Question 3. How much additional money do you think the FDA needs to
    carry out the Food Protection Plan?
        Answer 3. The activities recommended in the Import Safety Action
    Plan involve 12 different Departments and agencies and we are currently
    working on the implementation plans for the 14 broad recommendations
    and the 50 action steps. The requests for additional resources will be
    coordinated through the budget process for the affected Departments and
    agencies and result in requests for additional funding over a number of
    years. The President's fiscal year 2009 budget request will soon be
    presented to Congress and will include the first installment of funds
    to carry out these activities.

        Question 4. A significant impediment to the FDA doing a better job
    on food safety is its serious lack of adequate resources, as recently
    documented by the FDA Science Board Report. The Food Action Plan
    proposed two modest user-fee programs, on export certificates and re-
    inspections. How much money will each of these user-fees generate?
        Answer 4. For fiscal year 2008, the proposed food and feed export
    certificate user-fee program was estimated to collect $3.7 million, and
    the proposed user-fee for re-inspections was estimated at $23.3 million
    including foods and medical products-related activities.

        Question 5. Why does the Food Protection Plan propose requirements
    related to intentional contamination based on a risk assessment while
    allowing requirements for unintentional contamination based on repeated
    actual incidents of serious harm to consumers?
        Answer 5. When FDA conducts a food risk assessment, we take the
    following variables into account:

         the possibility that consuming a particular food will
    result in a foodborne illness due to contamination of the product,
    which depends on such factors as the number of microbes present or the
    level of a chemical or toxin present, the susceptibility of the person
    to the contaminating agent, and whether the food was properly handled
    and cooked;
         the severity of that illness, should it occur;
         the point in the production cycle where contamination is
    most likely to occur; and
         the likelihood of contamination and steps taken during the
    production cycle to reduce the possibility of contamination.

        Both the proposal to require additional preventive controls for
    high-risk foods (unintentional contamination) and the proposal to
    require preventive controls against intentional adulteration
    (intentional contamination) take this type of risk assessment into
    account. For the foods or food categories covered by the unintentional
    contamination proposal, FDA can identify these foods as ``high-risk''
    based on the known possibility of these foods causing illness, known
    instances of illness severity, and known data and experience around
    where the contamination is most likely to occur. The required
    preventive controls would then focus on known process control systems
    to reduce the possibility of contamination. The intentional
    contamination proposals take into account the same risk factors based
    on risk assessment modeling and best professional judgment in the
    absence of data and experience with these types of events in the United
    States. Therefore vulnerability assessments are required to suggest
    reasonable and appropriate mitigation measures given the number of
    uncertainties, and the fact that such attacks have not actually
    happened, around such events.

        Question 6. What is the rationale for protecting from liability
    companies that comply with requirements related to intentional
    contamination of food?
        Answer 6. This proposed authority would require companies to follow
    FDA requirements to prevent the intentional contamination of food.
    Recognizing that these requirements would be intended to help prevent
    the actions of third parties who may have ill intent and over whom the
    companies have no control, HHS determined that it would be appropriate
    to pair this proposal with an affirmative defense that would be of use
    if a third party were able to circumvent those required actions as
    fully implemented by the company. This does not provide full liability
    protection, but does allow a firm, if charged with negligence in a
    lawsuit, to have the benefit of an affirmative defense that it had
    fully complied with the relevant FDA requirements.
                          questions of senator harkin
        Question 1. I support mandatory recall authority for both USDA's
    Food Safety and Inspection Service (FSIS) and for FDA. However, I know
    that recall authority comes with a cost. How much would it cost to
    implement such authority and is FDA planning on requesting more funding
    for it in its fiscal year 2009 budget?
        Answer 1. FDA is seeking mandatory recall authority to be used only
    when the current process of voluntary recalls fails to promptly remove
    foods that present a threat of serious harm to people or animals. While
    FDA has been able to accomplish most recalls through voluntary actions
    by product manufacturers or distributors, there have been rare
    instances in which a firm was unwilling to conduct a recall. In such
    situations, FDA needs the ability to require a firm to conduct a recall
    to ensure the prompt and complete removal from distribution channels of
    food that presents a threat of serious harm to people or animals. In
    these rare situations this may result in a more efficient use of
    available FDA resources. The Administration is completing its work on
    the President's fiscal year 2009 budget request and will present the
    budget request to the Congress in February.

        Question 2. In the submitted witness testimony for the hearing, we
    have read that statutes need to be significantly changed to modernize
    our food safety system. Do you agree? If so, does FDA have a
    legislative proposal?
        Answer 2. The Import Safety Action Plan and the Food Protection
    Plan identify several legislative changes that would enable
    implementation of certain action steps and strengthen FDA's ability to
    continue to protect Americans from foodborne illnesses. Some of these
    are discussed in my written testimony. I look forward to working with
    you and other Members of Congress on these authorities.

        Question 3. In the FDA Food Protection Plan, FDA places a renewed
    emphasis on the threat of an intentional contamination of food. Please
    describe FDA's relationship with intelligence officials and any ongoing
    collaboration the agency has with Federal Government intelligence
    agencies.
        Answer 3. In July 2005, the Department of Homeland Security (DHS),
    the U.S. Department of Agriculture (USDA), the Food and Drug
    Administration (FDA), and the Federal Bureau of Investigation (FBI)
    announced a new collaboration with private industry and the States in a
    joint initiative, the Strategic Partnership Program Agroterrorism
    (SPPA) Initiative. The SPPA Initiative is a true partnership program,
    where an industry member, trade association or State may volunteer to
    participate in this vulnerability assessment program utilizing the
    ``CARVER + Shock'' method. The desired results of the SPPA Initiative
    include sharing:

         unclassified reports that detail generally identified
    vulnerabilities, possible mitigation strategies, and warnings and
    indicators of an attack. The unclassified reports will be distributed
    to all site participants;
         classified reports that outline sector-wide
    vulnerabilities and lessons learned to effectively and appropriately
    prioritize national assets and resources. The classified reports will
    be distributed to DHS, USDA, FDA, and FBI;
         the ``CARVER + Shock'' assessment tool, and adapting it,
    if necessary, to the unique production, processing, retail,
    warehousing, and transportation system for each sub-sector;
         lessons learned;
         assessment templates for each ``system'' by sub-sector
    that can be exported to other sites to identify vulnerabilities that
    incorporate existing tools;
         sector-specific investigative templates and field guides
    for the food and agriculture/intelligence sector; and
         research and development initiatives related to the food
    and agriculture sector.

        DHS has established the Homeland Infrastructure Threat and Risk
    Assessment Center (HITRAC), where intelligence analysts and
    infrastructure specialists work to identify the threat to critical
    infrastructures, vulnerabilities and interdependencies, and the overall
    risk inherent in any potential attack against critical infrastructure.
    The HITRAC has worked closely with the food and agriculture sector to
    ensure that the most complete, actionable, accurate information
    regarding private sector assets is disseminated expeditiously to key
    stakeholders.
        The Commissioner of FDA has designated the Office of Criminal
    Investigations (OCI) as the Agency's lead point of contact for liaison
    with the intelligence communities. OCI has several initiatives in place
    to fulfill their mission. Below is a sample and description of those
    initiatives.
        OCI has a counter-terrorism section located at OCI Headquarters
    with the capability and background to analyze information from law
    enforcement and intelligence community sources so that they can assist
    in terrorism-related threat assessments involving FDA regulated
    products and respond to assist the FBI in counter-terrorism cases where
    an FDA regulated product is involved. OCI special agents are assigned
    and serve on several interagency terrorism-related task forces
    including the FBI Joint Terrorism Task Forces (JTTF), U.S. Attorneys'
    Office Anti-Terrorism Task Forces, and select Regional Task Forces
    around the country.
        OCI's counter-terrorism efforts include daily contacts and
    interactions with the Central Intelligence Agency (CIA), the National
    Counterterrorism Center (NCTC), the Federal Bureau of Investigation
    (FBI), the Department of Homeland Security (DHS), the Defense
    Intelligence Agency (DIA), Customs and Border Protection (CBP), and the
    FDA-Prior Notice Center (PNC). In addition, OCI maintains relationships
    with domestic and foreign law enforcement agencies to receive and act
    on any information regarding threats to FDA-regulated products or
    incidents of actual product tampering. OCI also actively participates
    in the SPPA Initiative.
        Shortly after the September 11, 2001 attacks, the OCI counter-
    terrorism section organized an ``Agriculture Intelligence'' working
    group, referred to as ``AgInt,'' to address threats to U.S. agriculture
    from ``farm-to-fork.'' These monthly meetings include representatives
    from FDA (OCI, CFSAN, CVM, Import Ops, and PNC), the U.S. Department of
    Agriculture-USDA's Animal Plant Health Inspection Service (APHIS); Food
    Safety Inspection Service (FSIS); Agricultural Research Service (ARS);
    and the Office of the Inspector General (OIG), the FBI, the National
    Counter-Terrorism Center (NCTC), the CIA, the Department of Defense
    (DOD) and the Department of Homeland Security (DHS). These meetings are
    held at OCI Headquarters.
        OCI's counter-terrorism efforts successfully established and
    strengthened relationships between Federal, State and local law
    enforcement, and the food and agricultural industry.

        Question 4. Coordination across departments of the Federal
    Government is critical to ensuring the safety of our food supply. Does
    FDA currently use USDA resources (financial or personnel) for its food
    safety programs? Should this type of activity be encouraged to promote
    collaboration between the two agencies?
        I agree wholeheartedly with you about the importance of
    coordination and a closer collaboration within the Administration is a
    key element of the Import Safety Action Plan. The import community,
    U.S. Customs and Border Protection and other agencies will exchange
    real-time product and compliance data on each import transaction to
    better inform decisions to clear or detain import shipments. We also
    will pursue information sharing agreements with foreign regulatory
    entities.
        With regard to the relationship between the FDA and USDA, these
    agencies work closely together on food safety and food defense
    programs. This has been particularly evident in efforts to track cases
    of BSE in domestic cattle. FDA and USDA coordinate food safety research
    needs to address gaps and to avoid duplication. Another example of
    coordination with USDA is the Food Emergency Response Network (FERN).
    FDA has worked in close collaboration with USDA's Food Safety and
    Inspection Service to include a substantial number of laboratories
    capable of analyzing foods for agents of concern. FERN is a network of
    Federal, State, and local laboratories capable of testing food samples
    for microbiological, chemical, and radiological threat agents. This
    partnership provides essential analytical expertise and surge capacity
    in case of emergencies. In addition, the FDA, USDA, and other
    Departments will collaborate to improve the rapid response to interdict
    unsafe imports, and to use electronic track and trace technologies,
    where feasible.
                         questions of senator mikulski
        Question 1. In your testimony at the Senate HELP hearing on
    December 4, 2007, you noted that the FDA ``plans to develop
    international standards that reflect the same level of protection
    maintained for consumer products in the United States.'' I applaud this
    initiative and some of the suggestions you have made to Congress as a
    first step, such as authorizing FDA to accredit third parties for food
    inspections abroad. However, making sure that imported foods meet the
    same safety standards of U.S. foods from handling to packaging, and
    processing is a tall order. How do you plan to implement this standard?
        Answer 1. We have always required that imported foods meet the same
    safety standards as domestically produced products. However, the Import
    Safety Action Plan and the Food Protection Plan call for the
    implementation of export certificate programs for certain imported
    products and the development of third party certification programs to
    evaluate compliance with FDA requirements. In addition, we will
    continue to harmonize international standards through our participation
    in the Codex Alimentarious Commission and make import safety a key
    principle in our diplomatic relationships and trade negotiations with
    foreign countries. Together, these steps will help to elevate the
    standards of imported goods. Ultimately, however, import safety is a
    responsibility that must be shared by the public and private sector
    stakeholders involved in the imported products supply chain.

        Question 2. What regulations will you establish to determine
    whether a food product imported from another country meets the same
    safety standards as those required of foods in the United States?
        Answer 2. The Federal, Food, Drug and Cosmetic Act requires all
    food products distributed in the United States--whether produced
    domestically or abroad--to meet the same standards. In the Import
    Safety Action Plan and the Food Protection Plan we are proposing
    additional measures to supplement current authorities that would
    enhance FDA's ability to determine whether a food product imported from
    another country meets the same safety standards as those required of
    foods in the United States. In addition, stronger penalties and
    enforcement actions will be required to ensure accountability.
        Specifically, we propose to:

         Accredit Highly Qualified Third Parties for Voluntary Food
    Inspections;
         Refuse admission of food, if FDA's efforts to conduct a
    foreign inspection are unduly delayed, limited or denied at a facility
    where the product was manufactured, processed, packed or held; and
         Require electronic import certificates for shipments of
    designated high-risk products.

        Question 3. What plans do you have to provide foreign producers
    with incentives to upgrade their food safety systems?
        Answer 3. Under the current system, foreign producers and exporters
    already have a number of incentives for ensuring that their food
    products comply with U.S. safety requirements. First and foremost,
    foreign producers do not wish to run the risk of their product being
    refused entry into this country. In certain cases, after problems are
    encountered, future shipments are under more scrutiny through issuance
    of an import alert and, under FDA policies, may not be allowed to enter
    U.S. commerce unless the producer/exporter is able to establish that
    the products are in compliance, such as by satisfactory test results.
    Producers/exporters can suffer severe losses when their products are
    found not in compliance with FDA food safety requirements. For foods
    having a good record of compliance, on the other hand, FDA sets a
    higher ``may proceed'' rate so that the products are not held on entry
    into the United States for examination and possible testing. This
    higher ``may proceed'' rate enables food products to enter U.S.
    commerce faster.
        The Import Safety Action Plan recommends a number of additional
    steps to enhance foreign food safety systems. The certification
    programs which verify compliance of foreign producers with U.S.
    standards and the third party inspection programs will provide
    incentives to strengthen foreign food programs. In addition, we will
    step up collaboration and information sharing with foreign governments
    and regulatory bodies, develop good import practice guidances, best
    practices for track and trace technologies, and continue to work on
    food safety priorities through our diplomatic relationships and provide
    technical assistance to foreign regulatory entities. Finally, as we
    have done with China, we are entering into formal agreements with
    foreign governments.

        Question 4. What do you do right now if you find imported food that
    was handled under unsanitary conditions or has not been subject to
    controls that meet the U.S. level of protection?
        Answer 4. FDA can refuse admission of food offered for import if it
    appears that the food has been manufactured, processed, or packed under
    unsanitary conditions or is adulterated or misbranded. FDA gives notice
    to the owner/consignee stating the reason FDA believes the product is
    subject to refusal and explaining their right to provide evidence
    regarding the product's admissibility. If FDA ultimately concludes that
    a violation appears to exist, the product will be refused admission
    into the United States, and the importer is required to either export
    or destroy the product.
        If FDA finds a problem with a product or range of products from a
    particular producer, shipper, or importer, FDA can issue an import
    alert or import bulletin to signal FDA field staff to pay special
    attention to those products. For example, FDA may issue an import alert
    for ``detention without physical examination'' explaining that FDA
    staff may initiate refusal of admission of a product as soon as it is
    offered for import without first examining it and taking a sample. An
    import alert for detention without physical examination is based on
    information, such as the past history of the company or product,
    sufficient to support refusal of future shipments of the product.

        Question 5. How do you compare imported foods to those from the
    United States to determine if they meet the same level of food safety?
        Answer 5. All imported products that are regulated by FDA are
    required to meet the same standards as domestic goods. Imported foods
    must be pure, wholesome, safe to eat, and produced under sanitary
    conditions.
        FDA performs routine surveillance inspections of imported foods to
    check for compliance with U.S. requirements. While FDA is not able to
    physically inspect a large percentage of food entries, we
    electronically screen all import entries using an automated system,
    which helps our field inspectors determine which products pose the
    greatest risk and therefore should be physically examined.
        FDA also performs laboratory analysis on a sampling of products
    offered for import into the United States and performs periodic filer
    evaluations to ensure that the import data being provided to FDA is
    accurate. Certain violations relating to imported food may lead to
    civil or criminal charges.
                         questions of senator bingaman
        I was pleased FDA's Food Protection Plan discusses the importance
    of using risk-based technology to help FDA screen for potentially
    unsafe imports while facilitating the importation of safe products. For
    some time, I have helped fund the screening system called PREDICT
    (Predictive Risk-based Evaluation and Dynamic Import Compliance
    Tracking), which is under development for FDA by New Mexico State
    University. The concepts behind the PREDICT were proven in 2004 and
    successfully piloted this year as a part of FDA's import screening
    system.

        Question 1. What is FDA's timetable and budget to fully implement
    the PREDICT system?
        Answer 1. A pilot test of the PREDICT prototype system was
    conducted by FDA during the summer of 2007. The prototype system is
    currently limited to seafood and the pilot test was limited to seafood
    imported through a small number of ports in southern California. FDA
    has recently begun an expansion of the prototype to include all food
    products. Should this be successful, our plan is then to include other
    FDA-regulated commodities. The plan is to test the food prototype
    during fiscal year 2008 as it evolves, using the same few California
    ports, with feedback from the users. Considerable work must be done by
    subject-matter experts to develop the extensive risk-based criteria
    which will be required. Open-source intelligence activities must be
    expanded. A prototype integration of the PREDICT user screens into
    FDA's enterprise-wide import system will be developed. Technical
    requirements must be developed in order to ensure the final prototype
    represents a model which, when expanded to full production, will fully
    conform to applicable information technology standards. FDA estimates
    that completion of the prototype system will be accomplished during the
    first quarter of fiscal year 2009, and that deployment of a production
    version nationwide could begin thereafter within 6 to 9 months.

        Question 2. What is FDA's estimate over the next 5 years of the
    amount of funding needed to bring PREDICT to full operational
    capability?
        Answer 2. We have provided $1.0 million in fiscal year 2008 for
    this purpose and we intend to continue to support this important
    program. FDA is working to deploy these funds and will be able to
    determine estimates for future funding as we move forward.
                           questions of senator brown
        Question 1. How can we shift our focus at FDA to prevention in food
    safety rather than in responding to problems after they've already come
    about?
        Answer 1. This is a key point and one of the underpinnings of the
    Import Safety Action Plan and the Food Protection Plan. These call for
    risk-based prevention steps, which will move forward concurrently.
        1. Promote Increased Corporate Responsibility to Prevent Foodborne
    Illnesses.--FDA designed its plan for the full life cycle of food--from
    production to consumption, whether it be domestic or imported. The
    prevention elements of the plan emphasize the importance for FDA and
    corporations to work collaboratively to prevent food problems from
    occurring. Promoting increased corporate responsibility is key in
    shifting FDA's food protection effort to a proactive rather than a
    reactive one. The FDA will seek partnerships with industry to enhance
    consumer confidence. FDA will continue to work with industry in (a)
    developing food protection plans that address safety and defense
    vulnerabilities, (b) implementing prevention steps, and (c) developing
    contingency plans to improve response to an outbreak of foodborne
    illness.
        The FDA will primarily focus on promoting the use of risk-based,
    preventive systems that companies can apply at all levels of food
    production and processing, when appropriate. Voluntary approaches may
    be as basic as following good manufacturing practices to ensure proper
    equipment sanitation and employee safety training. Potentially high-
    hazard food categories may require additional control measures. FDA
    will work with industry, consumer, and Federal, State, local, and
    international partners to help model and promote preventive controls
    based on best industry practices.
        FDA plans to acquire additional data to develop a better
    understanding of foreign country practices for food and feed. This may
    include the examination of best practices around the food safety
    control systems of other countries as well as increased understanding
    of the difficulties faced in implementing food protection measures. FDA
    will also seek to share U.S. food safety and defense best practices
    with foreign governments and provide technical assistance, when
    possible, to those countries exporting food products to the United
    States so they can enhance their regulatory systems. As part of its
    review of foreign systems and products, the Agency will analyze food
    import trend data and integrate it into a risk-based approach that
    focuses inspection resources on those imports that pose the greatest
    risk. This approach will also focus foreign inspections on high-risk
    firms. In the near term, a special emphasis will be placed on firms
    located in countries where imports into the United States have been
    refused repeatedly and import violations have threatened the health of
    U.S. consumers.
        2. Identify Food Vulnerabilities and Assess Risks.--FDA actions
    will include gathering data for risk assessments and to conduct risk
    evaluations of commodity-agent combinations and relative risk ranking
    of commodities. A comprehensive, risk-based approach allows the FDA to
    maximize the effectiveness of its available resources by focusing on
    food products that have the potential to pose the greatest risk to
    human and animal health.
        By analyzing data collected throughout the food product life cycle,
    we are better able to detect risks posed by food products. We are also
    better able to recognize key junctures where timely intervention can
    reduce or avoid those risks. Working with CDC, FDA will also build the
    capacity to attribute pathogens to specific foods and identify where in
    the production life cycle the foods became contaminated.
        3. Expand the Understanding and Use of Effective Mitigation
    Measures.--Building on risk assessments, FDA will initiate basic
    research to enhance our understanding of sources of contamination,
    modes of spreading, and how best to prevent contamination. This
    information in turn will inform FDA's efforts above to promote
    increased corporate responsibility to implement effective preventive
    steps.
        Focusing on higher risk foods, FDA, working with other agencies,
    will undertake basic research and leverage relationships with outside
    organizations. The FDA will also research, evaluate, and develop new
    methods to detect contaminants in foods, and seek to facilitate new
    technologies that enhance food safety.

        Question 2. Last week, a draft report was released indicating that
    the FDA doesn't have the resources it needs to ensure the safety of our
    foods. What are you going to do to ensure that FDA has the funding it
    needs to do its job?
        Answer 2. The activities recommended in the Import Safety Action
    Plan involve 12 different Departments and agencies and we are currently
    working on the implementation plans for the 14 broad recommendations
    and the 50 action steps. The requests for additional resources will be
    coordinated through the budget process for the affected Departments and
    agencies and result in requests for additional funding over a number of
    years. The President's fiscal year 2009 budget request will soon be
    presented to Congress and will include the first installment of funds
    to carry out these activities.

        Question 3. Right now, the Food Safety Plan advocates a voluntary
    certification program where products are certified as meeting U.S.
    safety standards. Do you think these programs should really be
    voluntary? Wouldn't they be more effective if they were mandated?
        Answer 3. Voluntary certification programs are useful in helping
    FDA focus its resources on the areas of highest risk and will allow us
    to leverage the resources of reliable third parties. FDA will be able
    to facilitate the entry of products from certified firms while focusing
    its own resources on non-certified firms or firms for which FDA has
    reason to believe there are safety or security concerns. Such programs
    would be audited by FDA, and FDA would retain its authority to inspect
    those establishments, as appropriate.
        Mandatory certification can play an important role as well. For
    this reason, we recommend authority to require import certificates in
    certain circumstances. Mandatory programs require more time and
    resources to establish, but may be appropriate when the risks
    associated with a particular product, region, country, or producer are
    higher. Requiring mandatory certification for all products would be
    very resource intensive and could hinder trade unnecessarily.
                           questions of senator enzi
        Question 1. You indicate in your testimony that building
    interoperable data systems and encouraging data sharing is important to
    import safety. Can you tell me more about what is required to achieve
    this interoperability? What sort of new legislative authority would you
    need?
        Answer 1. FDA plans to enhance its information technology (IT)
    systems related to both domestic and imported foods. Many of these
    improvements will be implemented in the next 2 years; a few will extend
    beyond 2010. The enhancements described below do not require new
    legislative authority. The Mission Accomplishment and Regulatory
    Compliance Services (MARCS) program manages the integration,
    reengineering, and enhancing the legacy systems that support field
    activities. These systems include OASIS and other components which
    support import processing. Improvements range from replacing the
    current process that screens import entries; giving investigators
    faster access to product information via views of Center databases;
    improving sample collection/tracking on both desktop and mobile
    platforms; to developing a broker information center to allow Customs
    Brokers to quickly exchange information with import reviewers.
        In addition to MARCS, FDA is working on a number of related
    projects that will improve import safety in the next 2 to 3 years.
    These include:

         Working closely with CBP to ensure that its planned
    Automated Commercial Environment, a component of International Trade
    Data System, will provide the functionality long sought by FDA.
         Developing a standard way of finding, creating, and
    updating the information about facilities/enterprises FDA regulates.
         Enhancing FDA's Decision Support System to boost
    performance and expand its ability to rapidly access information.
         Ongoing data cleanup and upgrade of internal system
    interfaces to synchronize and validate data across centers and ensure
    rapid access to correct information.
         Substantially improving in the IT infrastructure that
    helps staff exchange data among field offices and between the field and
    Headquarters.
         Expanding of the Electronic Exchange Network that
    facilitates data sharing among public health partners and collaboration
    among food safety experts.
         FDA's Unified Registration and Listing System (FURLS)
    integration of the registration and listing systems currently
    maintained in the individual Centers.
         Developing a Product Quality System to encompass an
    electronic mechanism for manufacturers' registration and product
    listings, and capture inspection data from compliance reviews.
         Implementing FDA's Information and Computer Technologies
    plan for the 21st (ICT21) century to ensure that FDA has the
    infrastructure needed to support these IT initiatives and move towards
    the Bioinformatics era.

        Question 2. Third party inspection and review programs have a
    somewhat mixed track record. One common criticism is that companies
    don't use these programs because they would have to pay to be inspected
    more frequently, when they could just use the less-frequent and
    ``free'' government program instead. How do we ensure that third party
    review is sufficiently rigorous that it actually protects the public
    health, but isn't such a high standard that it deters people from using
    the program?
        Answer 2. We have confidence in FDA's third party inspection
    programs. FDA trains, accredits, and oversees the work of third party
    inspectors to ensure that their inspections are as rigorous as if FDA
    employees had conducted them. Moreover, FDA also maintains the right to
    inspect at any time. While it is true that many firms have not taken
    advantage of this option in the past with respect to the medical device
    third party inspection program, FDA is working to increase
    participation and we are pleased that FDA included needed improvements.
    In the international context, these types of inspections can play an
    important role. Because other countries also accept third party
    inspections, firms may be able to have one inspection that satisfies
    the requirements of several regulatory bodies. This will help to
    streamline the movement of imports.

        Question 3. I have some concerns about the proposed user-fee for
    re-inspections. I firmly believe that FDA needs more resources and more
    inspectors. However, if an inspector knows that FDA gets more money if
    he or she has to come back, I wonder if that creates a perverse
    incentive to find violations and fail companies. How do we guard
    against this potential conflict of interest?
        Answer 3. FDA's decision to re-inspect a facility or initiate
    regulatory action after a violative inspection is informed by the
    applicable Federal statute (i.e., Federal Food, Drug, and Cosmetic Act
    and Public Health Service Act), regulations, and agency policies and
    procedures. Neither the decision to take a regulatory action nor the
    decision to re-inspect a facility rests with the FDA Investigator. An
    FDA Investigator inspects regulated industry based on previously
    established Agency policies and procedures. The FDA Investigator's role
    is to inspect FDA-regulated industry in accordance with the
    requirements of our statute, regulations, and established Agency
    policies and procedures and to prepare a written account of any
    findings that appear to the Investigator to be out of compliance with
    the Agency's laws or regulations. Once the Investigator has written the
    inspection report explaining the inspectional findings, including the
    evidence necessary to support the observations, the report is further
    evaluated by other FDA personnel within the chain of command. The first
    line supervisor will review the report for accuracy and assurance that
    the observations are based on facts and supported by the evidence
    collected. The matter may then be referred to a District Compliance
    Office for review and evaluation to determine if the Agency should
    consider regulatory action. Depending on the specific FDA commodity and
    the governing Center within FDA, the regulatory action may also require
    review by other FDA offices to ensure that the action is consistent
    with various requirements, policies, procedures, and practices. If an
    action is taken, the determination whether a re-inspection is warranted
    is also weighed carefully to ensure that the decision is consistent
    with Agency policies and procedures. We believe that any perceived
    conflict of interest regarding our current proposal for user-fees for
    re-inspections is addressed by the current evaluation process FDA
    utilizes. Moreover, the proposed re-inspection fee only covers the
    actual costs of the inspection. There is no net revenue gain to FDA
    from conducting re-inspections.

        Question 4. Track and trace technologies are going to be an
    important part of our food safety system at some point, as you suggest.
    We heard a lot about Radio-Frequency Identification (RFID, a track and
    trace technology) at last year's hearing, but it seemed that the
    conclusion was that this technology isn't ready for prime time, at
    least at the unit-of-sale package level. What do we need to do to get
    to a point where track and trace is a reality?
        Answer 4. Over the years, FDA has monitored industry efforts to
    develop and promote RFID track and trace technology in the context of
    prescription drugs. Section 505D of the Federal Food Drug and Cosmetic
    Act, as amended by the Food and Drug Administration Amendments Act,
    gives the agency the authority to develop standards for the
    identification, validation, authentication and tracking and tracing of
    prescription drugs, and to develop a standardized numerical identifier
    to be applied to prescription drugs. Recognized standards will be
    useful to help promote the use of this technology, which the standards
    must address.
        For foods, however, it is not clear that RFID is the best, or only,
    technology appropriate for effective trace-back. HHS plans to work with
    stakeholders to develop an action plan for implementing more effective
    trace-back process improvements and technologies to more rapidly and
    precisely track the origin and destination of contaminated foods, feed,
    and ingredients. In so doing, it will be critical to identify best
    practices for the use of track and trace technologies to facilitate
    their adoption by industry.

        Question 5. In all three of the focus areas--prevention,
    intervention and response--there is a clear need for new science and
    technologies. What do you believe is the role of FDA's Critical Path
    initiative and the new Reagan Udall Foundation for the FDA in
    developing these new tools?
        Answer 5. Both the Import Safety Action Plan and the Food
    Protection Plan emphasize the need for new scientific and technology
    developments to ensure the safety of FDA regulated food products, both
    domestic and imported. These goals are also at the heart of the
    Critical Path Initiative, and activities under way under this
    Initiative directly support the achievement of these goals. For
    example, developing and implementing standards for data being collected
    and managed by FDA and progress the Agency is making to move into a
    wholly electronic environment will help the Centers identify and track
    problems, improving our ability to intervene and respond. Improving
    manufacturing approaches (one of the Critical Path's 6 key topics),
    such as building quality into manufacturing and packaging processes,
    will help ensure that products are manufactured, packaged, and stored
    safely.
        The recently enacted FDA Amendments Act of 2007 provides for the
    creation of the Reagan Udall Foundation. The Foundation is charged with
    advancing the mission of the FDA to modernize medical, veterinary,
    food, food ingredient, and cosmetic product development, accelerating
    innovation, and enhancing product safety. The statute specifically
    directs the Foundation to take into account the FDA's Critical Path
    reports and priorities. Thus, developing new science and technology for
    product safety in all three areas--prevention, intervention and
    response--should be within the Foundation's mission.

        Question 6. I agree that we need to do a better job of
    communicating about product recalls. One thing I've been thinking about
    a lot is retail food safety. Big chains hear about recalls, smaller
    ones often don't. I've been looking at the reverse-911 system that was
    used in southern California during the recent wildfires to tell
    residents to evacuate. I feel like there's a role for a system like
    that for communications up and down the supply chain during a recall.
    What do you think?
        Answer 6. Although companies generally comply with voluntary
    recalls, the Import Safety Action Plan includes a recommendation to
    seek authority for mandatory recalls when voluntary recalls are
    ineffective. Also, we are recommending cooperative agreements between
    Federal and State inspection entities and greater information sharing,
    the initiatives on track and trace technologies, and the proposal to
    develop a best practices model for expediting consumer notification of
    recalls. Together, these steps will significantly enhance the
    effectiveness of recall communications.
        In addition, FDA conducts recall effectiveness checks to determine
    whether a recall is progressing satisfactorily, with the number of
    checks dependent on the degree of the hazard. For example, during the
    recent Castleberry's Chili recall in July 2007, FDA conducted more than
    3,700 recall effectiveness checks. FDA will continue to explore new
    opportunities for optimizing recall communications to ensure our recall
    messages reach all of the necessary recipients.
                           questions of senator burr
        Question 1. From my perspective, the largest gap in the FDA Food
    Protection Plan was the lack of discussion about FDA resources. The
    data comparing the resources of the FDA to that of the USDA is
    startling and very troubling, especially given that the FDA regulates
    80 percent of the U.S. food supply. Are you requesting that OMB include
    more money for FDA food protection activities in the ``2009 budget,''
    if so, how much?
        Answer 1. The activities recommended in the Import Safety Action
    Plan involve 12 different Departments and agencies and we are currently
    working on the implementation plans for the 14 broad recommendations
    and the 50 action steps. The requests for additional resources will be
    coordinated through the budget process for the affected Departments and
    agencies and result in requests for additional funding over a number of
    years. The President's fiscal year 2009 budget request will soon be
    presented to Congress and will include the first installment of funds
    to carry out these activities.

        Question 2. Several witnesses will testify that the FDA Food
    Protection Plan limits the ability of the FDA to act in important food
    safety areas due to the proposed requirement that foods only come under
    process control programs if they have been linked to ``repeated,
    serious adverse health consequences or death.'' Peanut butter and
    spinach could probably not reach that level, but I think everyone
    agrees that the processing plants for both food products need control
    programs. Do you agree that the ``repeated, serious adverse health
    consequences or death'' bar may be too high?
        Answer 2. This is an important point. The proposed authority to
    require additional prevention controls for high-risk foods
    (unintentional contamination) is focused on those foods or categories
    of foods of greatest concern because of their known serious public
    health impact. Such authority would strengthen the FDA's ability to
    require manufacturers to implement risk-based HACCP or equivalent
    processes to reduce foodborne illness from these high-risk foods. It is
    appropriate to target prevention efforts where they can have the
    greatest public health impact.
        However, we are not ignoring other foods that do not fall into this
    category. HHS and FDA will work to consider safety and defense risks
    associated with foods through their whole life cycle whether
    domestically produced or imported. This includes the following actions:

         Meet with States and consumer groups to solicit their
    input on implementing preventive approaches to protect the food supply.
         Meet with food industry representatives to strengthen
    science-based voluntary prevention efforts, including developing best
    business practices and food safety guidelines.
         Develop written food protection guidelines for industry
    to: (a) develop food protection plans for produce and other food
    products and (b) implement other measures to promote corporate
    responsibility.
         Issue a final regulation requiring measures to prevent
    salmonella in shell eggs and resulting illnesses.
         Meet with foreign governments to share results of domestic
    prevention efforts and develop approaches for improving food safety at
    the source.
         Provide foreign countries with technical assistance so
    that they can enhance their regulatory systems.
         Analyze food import trend data and integrate it into a
    risk-based approach that focuses inspection resources on those imports
    that pose the greatest risk.
         Focus foreign inspections on high-risk firms and products.
         Improve FDA's presence overseas.

        Question 3. Mr. Corby will testify about the unique and successful
    partnership the State of New York has developed with the FDA. Does the
    FDA have plans to replicate that partnership with other States?
        Answer 3. Yes. FDA has posted the New York Department of
    Agriculture and Markets partnership agreement on the FDA Partnership
    Internet site and has made it available to all FDA Districts and the
    States. To the extent resources are available and States are willing to
    enter into these agreements, FDA has encouraged its District Offices to
    develop the appropriate partnerships to enhance the working
    relationships with the States within their districts.

        Question 4. Mr. Corby's written testimony mentions North Carolina's
    use of an Incident Command System for the chili sauce recall. Due to
    that system, NC performed more recall audit checks than the rest of the
    country combined. Do HHS and FDA have any intention of pushing more
    States to adopt Incident Command Systems?
        Answer 4. North Carolina demonstrated that its State
    infrastructure, the Incident Command System (ICS), functioned
    exceptionally well during a national recall. FDA has been working on
    the use of an Incident Command System process and recommended that
    basic ICS training include ICS-100 (Introduction to Incident Command
    System), ICS-200 (ICS for Single Resources and Initial Action
    Incidents), ICS-700 (National Incident Management System (NIMS), An
    Introduction), and ICS-800 (National Response Plan (NRP), An
    Introduction) on-line training courses for FDA staff who may be called
    upon to respond and manage emergency incidents.
        In 2007 and 2008, the FDA's Office of Crisis Management/Office of
    Emergency Operations and the Office of Regulatory Affairs began a
    series of ICS training classes to be held across the country in
    National Incident Management System (NIMS), ICS 300 (Intermediate ICS
    for Expanding Incidents) and ICS 400 (Advanced ICS). The target
    audiences for these classes are both FDA and State officials with a
    goal of integrating response operations across Federal, State, and
    local jurisdictions.

        Question 5. I'm pleased the FDA Food Protection Plan includes
    strategies to protect the food supply from intentional contamination--
    known as food defense. In my view, it doesn't matter if food is
    contaminated unintentionally or intentionally--we should be prepared
    for both. As you know, the human health and economic consequences of a
    deliberate attack on our agriculture and food system could be massive.
    And we know from intelligence sources that some folks are interested in
    acquiring the ability to do so. Mr. Secretary, how are you working with
    DHS and USDA to ensure a coordinated approach to protecting the
    agriculture and food system from biological, chemical, or radiological
    contamination?
        Answer 5. The National Strategy for Homeland Security and the
    Homeland Security Act of 2002 served to mobilize and organize our
    Nation to secure the homeland from terrorist attacks. The homeland
    security goals to prepare for, and respond to, such events are set
    forth in Homeland Security Presidential Directives (HSPDs) 5, 7, 8 and
    9. HSPD-5 ensures that all levels of government responding to an
    incident of national significance have the capability to work
    efficiently and effectively together using a common national domestic
    incident management approach, and HSPD-8 provides guidance on how to
    prepare for such a response, including prevention activities. HSPD-7
    focuses on issues concerning protection of all national critical
    infrastructures and key resources, the majority of which are owned and
    operated by the private sector. HSPD-9 represents a major step toward
    establishing a comprehensive national policy to defend the food and
    agriculture system against ``terrorist attacks, major disasters and
    other emergencies.''
        Significant progress in the Food and Agriculture Sector, one of the
    identified Critical Infrastructures, on homeland security goals can
    only be accomplished through a partnership effort between all levels of
    government and those who own the Critical Infrastructure. The Food and
    Agriculture Sector Coordinating Council (SCC) was formed as part of the
    private sector response. The SCC is a self-governing body representing
    the food and agriculture industry. It provides a forum for the private
    sector to discuss infrastructure protection issues among themselves and
    to communicate with the government through the Government Coordinating
    Council (GCC). The GCC, with representation from Federal, State, Tribal
    and local governments, is the public sector component of the food and
    agriculture public-private partnership framework. The objective of the
    GCC is to provide effective coordination of food and agriculture
    security strategies and activities, policy, and communication across
    government and between the government and the Sector to support the
    Nation's homeland security mission. The GCC conducts monthly conference
    calls to discuss infrastructure protection issues. Also, monthly calls
    are held between the leadership for the GCC and SCC to discuss
    infrastructure protection issues. The Food and Agriculture Sector holds
    a joint face-to-face GCC/SCC meeting each quarter to discuss issues of
    concern. Finally, the Food and Agriculture Sector is also populating an
    electronic notification system with contact information for the GCC and
    SCC members so that we can convene a meeting of the sector members on
    short notice.
        In July 2005, the Department of Homeland Security (DHS), the U.S.
    Department of Agriculture (USDA), the Food and Drug Administration
    (FDA), and the Federal Bureau of Investigation (FBI) announced a new
    collaboration with private industry and the States in a joint
    initiative, the SPPA Initiative. The SPPA Initiative is a true
    partnership program, where an industry member, trade association or
    State may volunteer to participate in this vulnerability assessment
    program utilizing the ``CARVER + Shock'' method. The desired results of
    the SPPA Initiative include sharing:

         Unclassified reports that detail generally identified
    vulnerabilities, possible mitigation strategies, and warnings and
    indicators of an attack. The unclassified reports will be distributed
    to all site participants.
         Classified Reports that outline sector-wide
    vulnerabilities and lessons learned to effectively and appropriately
    prioritize national assets and resources. The classified reports will
    be distributed to DHS, USDA, FDA, and FBI.
         The ``CARVER + Shock'' assessment tool, and adapt, if
    necessary, to its unique production, processing, retail, warehousing,
    and transportation system for each sub-sector.
         Lessons learned.
         Assessment templates for each ``system'' by sub-sector
    that can be exported to other sites to identify vulnerabilities that
    incorporate existing tools.
         Sector-specific investigative templates and field guides
    for the food and agriculture/intelligence sector.
         R&D initiatives related to the food and agriculture
    sector.

        Conducting face-to-face CARVER + Shock evaluations is resource-
    intensive and limiting in terms of the number of evaluations that can
    reasonably be conducted in any given timeframe. Therefore, the FDA has
    sponsored the development and delivery of a CARVER + Shock software
    tool that can be downloaded for free. In developing this software, FDA
    worked closely with USDA and beta tested the software with DHS in order
    to ensure maximum applicability. By having an on-line, free to use,
    CARVER + Shock software that produces results equivalent to those of a
    face-to-face session, any member of the food processing industry now
    has the ability to conduct a vulnerability assessment of their
    facilities and processes in a confidential manner. This CARVER + Shock
    software tool went live on our Web site in late June 2007 and has
    already been downloaded more than 2,000 times. The software tool is
    expected to be used by State and local food security agencies,
    industrial providers and any other parties interested in food defense.
    The tool is designed for use throughout the food processing industry.
        In addition, FDA in cooperation with the Centers for Disease
    Control and Prevention, USDA, and State and local organizations
    representing food, public health, and agriculture interests announced a
    new food defense awareness initiative, ALERT. The ALERT initiative is
    designed to provide a uniform and consistent approach to food defense
    awareness at any point in the food supply chain, from farm to retail
    establishment. ALERT identifies five key points that industry and
    businesses can use to decrease the risk of intentional food
    contamination. The five key points are as follows:

        A--How do you ASSURE that supplies and ingredients you use are from
    safe and secure sources?
        L--How do you LOOK after security of the products and ingredients
    in your facility?
        E--What do you know about your EMPLOYEES and people coming in and
    out of your facility?
        R--Could you provide REPORTS about the security of your products
    while under your control?
        T--What do you do and who do you notify if you have a THREAT of
    issue at your facility, including suspicious behavior?

        We have prepared ALERT materials in several languages (English,
    Spanish, Chinese, Korean, and Vietnamese) and offer training on our Web
    site that is suitable for State, local, and industry stakeholders.
        These are just a few of the many activities we have undertaken to
    protect against vulnerabilities and to coordinate and share information
    with our food defense partners.

        Question 6. In November, FDA awarded grants to three Food Emergency
    Response Network (FERN) labs to improve the ability to detect
    radioactive material in food resulting from deliberate or accidental
    contamination. How will these new radiological screening and analysis
    capabilities fit into the overall food defense surveillance strategy
    supported by FERN?
        Answer 6. The new radiological screening and analytical
    capabilities are targeted toward enhancing detection of radiological
    contamination and strengthening the Nation's overall capability to
    rapidly detect and respond to deliberate attacks on the food supply.
        These enhanced capabilities further expand the FDA's advancement of
    the integrated strategy for protecting the Nation's food supply by
    their direct application in the three core elements of prevention,
    intervention, and response as outlined in the agency's Food Protection
    Plan. Laboratories with the established radiological capabilities will
    be involved in food defense surveillance testing and will bolster the
    FDA's emergency response efforts by increasing the capacity for testing
    of foods for radioactive contamination, whether intentional or
    accidental.

        Question 7. Do you perceive the user-fee outlined in Chairman
    Dingell's bill to be a tax or a user-fee?
        Answer 7. We would note that a user-fee relating to imports would
    need to be consistent with U.S. obligations under treaty. While
    deferring to the United States Trade Representative (USTR) in this
    area, we understand that under Article VIII of the General Agreement on
    Tariff and Trade (GATT), fees--other than import duties and other taxes
    covered by another GATT provision--must be limited in amount to
    approximate the cost of services rendered and must not represent an
    indirect protection to domestic products or a taxation of imports for
    fiscal purposes.

        Question 8. Do we need mandatory, enforceable, on-farm standards
    for safe produce production (as suggested by Mr. Taylor) or voluntary
    food protection plans as outlined by the FDA Food Protection Plan?
        Answer 8. We believe that the development of written food
    protection guidelines to facilitate industry food protection plans for
    produce is an important step to ensuring produce safety. These
    guidelines would make a significant contribution to shifting the focus
    of produce safety from response to prevention, would call attention to
    corporate responsibility, and likely could be implemented significantly
    faster than a mandatory approach. In addition, FDA continues to explore
    additional actions it might take to improve produce safety. In 2007,
    FDA held two public hearings on produce safety which included the
    solicitation of all our stakeholders on ways to improve the safety of
    fresh produce. More specifically, FDA requested comments on what new
    Federal actions, if any, are needed to enhance the safety of fresh
    produce. FDA will continue to work with industry, consumer, and
    Federal, State, local, and international partners to comprehensively
    review food supply vulnerabilities and develop and implement risk
    reduction methods.
                           questions of senator hatch
        Question 1. You have proposed a role for accredited third parties
    to evaluate compliance with FDA requirements. Ever since the Medicare
    program began, third parties have evaluated whether hospitals comply
    with Medicare requirements. Very little inspection is done by Federal
    workers. Can food safety follow the Medicare model?
        Answer 1. The Import Safety Action Plan and the Food Protection
    Plan acknowledge that the ever-increasing volume of imported products
    and the complexity of food safety issues associated with them require
    an approach other than an exclusive reliance on examinations and
    analyses performed when products reach U.S. ports of entry. We have
    called for ``pushing out the borders'' by incorporating information
    about how the product was produced and the food safety controls and
    checks that were in place during its production into the import entry
    decision making process. This information can come from the processor,
    the government of the country in which it was produced, or reliable
    third-party, nongovernmental organizations. Such work is already done
    by these entities and information about those efforts could be used to
    inform the FDA entry review process. If the information that is
    obtained is sufficient to conclude that the risk of product
    adulteration or misbranding is significantly reduced, then the need for
    FDA examination or testing may be similarly reduced. That could enable
    FDA to shift those resources to riskier products, for which there is
    little or no information about its life cycle. FDA is working to
    develop these kinds of systems to improve the efficiency and
    effectiveness of U.S. control over imported foods. FDA does not
    envision that these systems will take the place of sampling and
    examination at the port of entry, but does envision that they will be
    an important component of the overall entry control system. Of course,
    third party information, whether it is derived from a governmental or
    nongovernmental source, is only as valuable as the accuracy and
    integrity of the information. For that reason, the Import Safety Action
    Plan and the Food Protection Plan both acknowledge the need for
    auditing and/or accreditation systems for third party certifiers.
        A third party inspection system for food safety could have many
    similarities with the Medicare hospital model. However, one major third
    party in the United States is responsible for hospital inspections
    whereas we envision multiple third parties will be necessary to conduct
    food establishment inspections worldwide.

        Question 2. What is the role of accredited third parties in other
    countries?
        Answer 2. Official accreditation is the procedure by which a
    government agency having jurisdiction formally recognizes the
    competence of an inspection and/or certification body to provide
    inspection and certification services on its behalf. Depending on the
    program, an officially accredited third party may either: (1) carry out
    inspections and tests directly on the agency's behalf to ensure that a
    product is in conformance with requirements; or, (2) certify an entity
    (e.g., conformity assessment service/inspection service/laboratory) to
    carry out services according to specified criteria.
        The role of accredited third parties is to ensure that products
    meet requirements. This is the case whether accredited third parties
    carry out their work in other countries with respect to imported food,
    or whether they carry out their work domestically on domestically-
    produced food. This is also the case whether such third parties
    accomplish their objectives through direct product inspection and/or
    testing, or whether they accomplish the objective indirectly, e.g.,
    certifying another body to actually inspect and/or test the product.
    For example, Australia permits the utilization of accredited foreign
    third parties to ensure that quality management systems are in place
    for a specific food producing firm/establishment to ensure that
    Australia's food safety requirements are met. Food produced by such
    firms/establishments is permitted to enter Australia at its lowest rate
    of inspection.

        Question 3. What are the advantages and disadvantages of seeking
    agreements with other countries to recognize the same accredited third
    parties?
        Answer 3. The principal advantage of having an agreement with
    another country which recognizes the same accredited third parties is
    the potential for enhancing information sharing. Since regulatory
    requirements for a food normally differ between countries, it would not
    be expected that an agreement with a country to mutually recognize an
    accredited body would result in accepting the other's country data for
    regulatory purposes. However, having in place an agreement to recognize
    the same accredited third party should increase confidence in the data
    gathered by the third party for either country and should enhance data
    sharing. This data sharing could provide significant industry as well
    as consumer health benefits and could result in better targeting of
    scarce resources.
        There do not appear to be obvious disadvantages for two countries
    seeking an arrangement to recognize the same third party. Presumably
    the accredited third party treats each country as a separate and unique
    client. If confidentiality and conflict of interest requirements differ
    between the two countries, these two areas could become difficult
    obstacles to overcome, but would not necessarily be disadvantages.

        Question 4. Could mutual recognition of accredited third parties
    speed harmonization of standards across countries?
        Answer 4. Harmonization of standards can refer both to specific
    national standards for food products and to standards for assessing
    conformance by assessment bodies such as third party certifiers. It
    would not be expected that mutual recognition of accredited third
    parties would result in any harmonization of specific product
    standards. However, the mutual recognition of an accredited third party
    by two or more countries using an agreed upon specific set of criteria
    could speed the use of the criteria as an assessment standard,
    particularly if those countries were influential in world trade
    discussions.
                          questions of senator allard
        Question 1. Can you describe how the recommendations by the working
    group, and FDA, would have avoided and/or more quickly addressed the
    issues that arose in relation to our domestic food supply over the past
    year? Please address, specifically those dealing with E. coli
    contaminated spinach and salmonella contaminated peanut butter?
        In your opinion did the current system effectively address these
    issues in a timely manner?
        What did your agency learn from these situations, and how were
    these concerns taken into account when making the recommendations that
    you have discussed today?
        Answer 1. The investigation into the E. coli outbreak linked to
    bagged fresh spinach in 2006 determined that a number of the Good
    Agricultural Practices recommended by FDA were not being followed on or
    near the field implicated as the source of the contaminated spinach. As
    part of the Food Protection Plan announced by FDA in November, FDA will
    strive to ensure that Good Agricultural Practices are being implemented
    on produce farms in the United States and on farms in other countries
    that export produce to the United States.
        FDA responded immediately to the outbreak upon learning that fresh
    bagged spinach had been implicated as the vehicle in the outbreak. FDA
    was told of the link to fresh bagged spinach late in the day on
    September 13, 2006. FDA and the California Department of Health
    Services had staff in the packing house on September 14, and FDA issued
    a warning to the public the same day. Your response to the outbreak
    could not have been any faster.
        Similarly, FDA was informed that peanut butter had been implicated
    in the Salmonella Tennessee outbreak on February 13, 2007. FDA
    contacted ConAgra, the manufacturer, that same evening. FDA and the
    Georgia Department of Agriculture had staff in the manufacturing plant
    the next day, and FDA issued a press release alerting consumers not to
    eat peanut butter under the brands Peter Pan and Great Value.
    Subsequent press alerts were issued as greater knowledge of the scope
    of the contamination was determined over the course of the
    investigation.
        FDA's response was timely and communications were consistent with
    the information we had about the scope of the problem. While we worked
    to ensure timely and coordinated communications with stakeholders, we
    are seeking to enhance communications and outreach with industry, State
    and local government partners. The Food Protection Plan has a component
    focused on improving communications.
        Consistent with the Food Protection Plan's three main themes of
    Prevention, Intervention and Response, we are seeking to build safety
    into the production of produce and manufactured foods, verify
    prevention and intervene when risks are identified, and respond rapidly
    and appropriately when outbreaks occur.

        Question 2. In your opinion what can be done to further educate the
    public, private sector and interested government agencies on food
    safety, recalls, etc.''
        Answer 2. We currently engage in a large portfolio of activities
    related to educating the various stakeholder groups, many of these in
    partnership with other Federal agencies. There are additional
    activities that we could engage in to further educate the stakeholders
    listed above regarding food safety and recalls. To reach the broadest
    population of stakeholders, TV and alternative mass media campaigns
    need to be considered. Curriculum for elementary, middle, and high
    schools relative to food safety could also be considered. In some
    cases, the information provided to the children will serve to educate
    their parents. We are exploring a reinvigoration and associated
    marketing campaign of our branded Web site, www.foodsafety.gov, shared
    among USDA, CDC and FDA, where stakeholders can find food safety
    information and information on recalls. Routine public safety
    announcements and radio spots could be increased in frequency and
    content. In short, we need to use the media and our schools more
    broadly for food safety and recall educational purposes.
        With regard to recalls, the recalling firm has the primary
    responsibility to effectively and rapidly remove problem products from
    the marketplace. FDA carefully monitors, advises or provides direction
    in the recall efforts, and often undertakes additional steps to enhance
    recall effectiveness by issuing press releases, posting information on
    the FDA Web site, disseminating information to our State regulatory
    partners, and by making Agency experts available for inquiries from
    media, industry, or consumers. We recently began posting photographs of
    recalled food items on the FDA Web site for significant recalls to
    enhance the public's ability to accurately identify the problem
    products. For the most significant ones, FDA establishes dedicated
    pages on the FDA Web site where all the most current information
    relative to a recall can be found. In addition, consumers and
    businesses can now subscribe to a Listserve available on FDA's Web site
    (http://www.fda.gov/opacom/7alerts.html) that will automatically
    provide information via e-mail on recalls, market withdrawals and
    safety alerts. This Web site also allows the public and private sectors
    to query the system for information on specific recalls. We plan to
    assess existing FDA consumer materials to determine if additional
    resources on where to find recall information is required for the
    consumer. We will continue to engage consumer groups for input on
    optimizing recall communications.
        There are, however, additional activities FDA can pursue to ensure
    even greater public awareness of food-related recalls and we are
    exploring other options.
       Response to Questions of Senators Kennedy, Harkin, Enzi, Burr and
                          Allard by Michael R. Taylor
                          questions of senator kennedy
        Question 1. There's a lot of real value in the Food Protection
    Plan, however, one thing that concerns me is that the plan proposes
    allowing the agency to require process controls for a food, but only
    after the food is associated with repeated instances of serious adverse
    health consequences or death. Why should the FDA have to wait for
    children or the elderly to die or be seriously injured by a food before
    companies making it are required to make it safely?
        Answer 1. FDA should not have to wait until people are hurt before
    requiring that food producers and processors implement commonsense
    preventive-process controls. We should instead be taking a public
    health approach to food safety, which means focusing on preventing
    problems that can make people sick rather than merely reacting to
    problems after people are hurt. And the fact is that many companies
    already implement modern process control procedures to prevent food
    safety problems. My recommendation is that Congress should mandate
    preventive process control, flexibly adapted to a company's particular
    circumstances, as the proper standard of care for all food companies.

        Question 2. A significant impediment to the FDA doing a better job
    on food safety is its serious lack of adequate resources. I believe the
    President should propose a substantial increase in FDA's budget and the
    Congress should increase appropriated funds to the FDA. Assuming that
    won't happen, or that increases won't be sufficient, I'd like you to
    comment on some ways to leverage FDA resources:

         a third party program for inspection and laboratory
    testing;
         fees on the food industry, such as an annual registration
    fee;
         enhanced collaborations with States and localities.

        Answer 2. I agree with the Chairman that, ideally, FDA's public
    health regulatory programs should be fully and adequately financed with
    appropriated funds. If that doesn't happen, however, I think all three
    of the suggested ideas have promise as ways to leverage or enhance FDA
    resources.
        Many food companies already undergo third-party audits to verify
    they are operating state-of-the art preventive process control systems
    in response to the demands of their commercial customers, such as
    restaurant and grocery chains. Such audits could be a useful surrogate
    for FDA inspections if the auditors could be accredited by FDA or some
    other credible body to verify their independence and qualifications and
    if records of their audits were readily available to FDA. FDA could
    then focus its resources on companies that are not subject to such
    audits. I see somewhat less potential for leveraging private laboratory
    capacity. The network of commercial laboratories that already exists
    plays a useful role in performing testing to support the industry's
    process control needs, and efforts should continue to ensure that such
    labs are properly accredited and reliable. FDA should be able to
    consider data from demonstrably reliable private labs in the course of
    its regulatory decisionmaking. Such private testing capacity can never
    substitute, however, for FDA having substantial, first-tier lab
    capacity in-house for the testing needed to support its inspection and
    enforcement activities.
        With respect to fees on the food industry, I think a well-
    structured annual registration fee system may be the most equitable way
    to generate a significant base of resources for FDA's food safety
    program. The very large number of domestic and foreign food
    establishments under FDA's jurisdiction would make it possible to raise
    significant sums while keeping the per establishment fees very modest,
    and this would avoid any sense that the agency was dependent on or
    beholden to any small group of companies for its resources. It would be
    important to make clear that, in its use of its food safety resources,
    FDA is properly accountable to the public and the Congress, not the
    food industry.
        Finally, enhanced collaborations with State and local agencies
    should be an important element of a modernized national food safety
    system, regardless of concerns about resources, but I also agree that
    through more active partnerships with States and localities, FDA can
    achieve much more to improve food safety than it ever could on its own.
    There are over 3,000 State and local agencies, including health and
    agriculture departments, local sanitarians, and public health
    laboratories, working on some aspect of food safety. In addition to
    their traditional role as the front-line regulators and inspectors of
    retail food establishments and investigators of food-borne disease
    outbreaks, State and local agencies can play an important role in the
    enhanced food safety oversight that is needed on the farm. In the end,
    we need an integrated, national food safety system that takes full
    advantage of the expertise and resources available at all levels of
    government.

        Question 3. You raised concerns about relying on voluntary efforts
    by the industry. Could you please expound on the problems with a
    voluntary approach to food safety?
        Answer 3. First, I recognize and respect the fact that many leading
    companies are making efforts to implement modern, state-of-the-art food
    safety procedures that go well beyond any government requirement.
    Indeed, historically, and still today, much of the on-the-ground
    innovation in food safety has come from the food industry, including
    HAACP (Hazard Analysis and Critical Control Points), which represents a
    standard of care for preventive process control that is widely accepted
    among food safety experts and practitioners. Companies that implement
    these procedures know that it is in their best business interest to do
    so in light of the nature of the markets in which they operate and the
    demands of their customers. Many companies also are committed to food
    safety because it is the right thing to do.
        Unfortunately, some companies operate in markets that are driven by
    low cost rather than high quality or high safety standards, and not all
    companies have the same level of internal corporate commitment to food
    safety. That is why we need regulation: to ensure that all participants
    in the commercial market for food observe a well-defined standard of
    care for food safety that meets reasonable public expectations. Efforts
    by government to ``encourage'' voluntary improvement in food safety
    practices by companies that are not otherwise committed to them for
    business or other reasons can easily be ignored and can have at best a
    transitory effect. In a voluntary system, when the government efforts
    at encouragement flag, marketplace and business reality take over, and
    there is no mechanism in place for holding companies accountable for
    observing a standard of care based on prevention of food safety
    problems. The government is left in a reactive mode, able to seek
    correction only after a problem has been found with food in the
    marketplace or after someone has gotten sick. The public--and companies
    that already follow proper food safety procedures--expect and deserve
    better.

        Question 4. You argue that every food company should have a plan to
    prevent food safety problems. Some would argue that such an approach is
    not risk-based, is over-regulatory, and will require companies to spend
    money for little gain in food safety. How would you respond to these
    concerns?
        Answer 4. This is an important point: modern preventive process
    control is inherently risk-based and flexible in the sense that it
    involves companies tailoring their preventive controls to the
    particular hazards that are likely to arise in their operations and to
    their own production or manufacturing system. Some plants are
    inherently low-risk and can have very simple food safety plans, while
    others may require more robust plans to deal with more significant
    potential hazards. I also think that, in crafting a legislative mandate
    in this area, Congress should recognize the need for flexibility in
    implementing a comprehensive requirement for food safety plans based on
    preventive controls. Small businesses should be given technical
    assistance and more time to comply; all firms should get clear guidance
    to facilitate the implementation of plans that add to the level of food
    safety assurance without being unduly burdensome. The point is not to a
    have a plan that exists just to satisfy a regulatory requirement but
    rather to have a plan that helps a company have confidence--and be able
    to assure customers--that proper steps have been taken to make the food
    safe.

        Question 5. What can the HELP Committee, which is an authorizing
    committee and not the Appropriations Committee, do to increase the
    frequency with which food facilities are inspected?
        Answer 5. One of the critical policy issues in considering reform
    of the food safety system is the role of inspection and the nature and
    frequency of inspection sufficient to be effective. This is very much
    an issue for the HELP Committee. In my view, inspection should be seen
    as part of an overall program to ensure a high level of compliance with
    food safety standards. Some minimum frequency of inspection is no doubt
    needed for this purpose, and one thing Congress could do is mandate a
    minimum frequency, while also recognizing that some food establishments
    pose a higher risk of non-compliance than others--and thus merit more
    frequent inspection--based on the inherent nature of their operations
    and their own performance over time. By establishing through
    authorizing legislation a modern, risk-based inspection mandate that
    includes measures of performance for FDA in terms of frequency of
    inspection and levels of compliance with food safety standards,
    Congress will have given the Appropriations Committees a benchmark
    against which to consider necessary funding levels.

        Question 6. You talked about food safety from farm-to-table. Ms.
    Smith DeWaal talked about food safety on farms, and Mr. Dooley
    mentioned good agricultural practices for produce. Traditionally, the
    FDA doesn't play a huge role on farms or at retail establishments. Do
    you have some suggestions about how we could enhance FDA's role there
    without raising the obvious sensitivities? What role can the States
    play?
        Answer 6. A true public health, preventive approach to food safety
    has to consider the full spectrum of the food system, from farm-to-
    table, because risks and opportunities to reduce risk exist all across
    that system. Both the production (on-farm) and retail ends of the
    spectrum present unique challenges for any food safety regulatory
    strategy, however, that are quite different from those that arise in
    food processing establishments. And I agree that these differences and
    some of the special sensitivities that exist, especially on the farm,
    need to be considered, and I think State and local agencies have
    important roles to play, both on the farm and at retail.
        One of the challenges on the farm is that there are so many
    independent farming operations of enormous diversity in terms of the
    products they produce, the conditions under which they produce them,
    and, especially, their size. Moreover, historically, while animal
    producers have been subject to regulation with respect to their use of
    pesticides and animal drugs, they have been left largely out of the
    food safety system's efforts to reduce the burden of foodborne illness
    associated with pathogenic microorganisms. This is despite the fact
    that the basic concepts of preventive process control that can reduce
    risks in processing plants can be applied on the farm. Preventive
    controls on the farm need to be pursued, however, by recognizing the
    diversity of operations and working with agricultural producers to
    craft approaches that are flexible and adaptable to diverse conditions.
    It may be appropriate, for example, to focus the scope of any
    regulatory requirements on the farm where they can do the most good for
    food safety by exempting certain commodities, such as grains, and
    possibly small producers. The fact is that a large percentage of the
    Nation's supply of fresh produce that is vulnerable to dangerous
    contamination is produced by a relatively small number of large
    producers. In addition, government oversight on the farm should take
    full advantage of State and local agencies for inspection and other on-
    farm activities. In my view, standards should be set nationally, while
    on-farm verification that standards are being met could be done
    principally by State and local inspectors or accredited third-party
    inspectors.
        At retail, State and local agencies already take the lead in
    inspection under a longstanding collaboration with FDA, which
    recommends through its model Food Code science-based standards and
    procedures for preventing food safety problems. At their discretion,
    States and localities adopt and enforce Food Code provisions or other
    standards and thus play the front-line role on retail food safety. This
    should continue. It is neither feasible nor desirable to have Federal
    inspectors inspecting every grocery store and restaurant in the
    country. Instead, the focus should be on strengthening the State and
    local roles by creating greater Federal incentives for adoption of the
    Food Code and greater Federal support for State and local compliance
    programs through technical assistance, training, and investment in
    local laboratory capacity.

        Question 7. You testified about how important increased resources
    are for the FDA. How much does the FDA currently have for inspections?
    How much does it need? Do you have a sense of what the agency could do
    with another $10 million? Another $100 million?
        Answer 7. FDA's total field budget for the food program in fiscal
    year 2007 was about $300, which supported a total field workforce of
    about 1,900, including inspectors and the laboratory personnel and
    compliance officers needed to test products and build cases based on
    the work of the inspectors. This workforce has to cover nearly 50,000
    domestic processing establishments and nearly three times that number
    overseas, which account for millions of import shipments annually. FDA
    inspects most domestic plants rarely if at all, tries but fails to
    inspect all ``high risk'' seafood plants annually, visually inspects
    less than 1 percent of import shipments, and actually tests less than a
    fifth of those. I recite these facts to illustrate my view that a $10
    million increase would be insignificant in relation to the challenges
    FDA faces and that even a $100 million increase, by itself, would not
    solve FDA's funding problem over the long haul.
        I personally think that the budget for FDA's field force needs to
    double in real terms in order to keep up with the growing complexity of
    food safety problems and the flood of imports. But, to be effective,
    FDA's field force needs more than additional resources: it needs to be
    deployed in support of a new preventive strategy--one that empowers
    FDA's field force to hold companies accountable for implementing having
    appropriate preventive controls, rather than FDA being in the business
    of simply detecting and correcting problems. At any realistic funding
    level, FDA will never have enough inspectors to adequately protect food
    safety if they are working in their present, largely reactive mode.

        Question 8. I understand FDA now inspects food facilities on
    average every 10 years. I think it's unlikely that appropriated money
    will increase enough, or that a user fee program could raise enough
    money, to allow FDA to inspect every food facility annually or even
    every 2 years. So there might be some value in a third party inspection
    program, if companies were to participate in it. Would you support such
    a program? Under what conditions?
        Answer 8. I think a third-party inspection or ``audit'' program can
    add value to the food safety system by providing a credible,
    independent source of verification that a company has in place the
    right preventive controls and that the controls are working properly.
    Government inspection resources could then be deployed more toward
    companies that are not subject to such third-party inspections. To be
    relied on for any governmental purpose, however, at least the following
    conditions should apply: (1) the auditing firms must be accredited and
    the auditors certified as meeting prescribed standards of training and
    experience, (2) the records of their audits must be readily accessible
    to FDA; (3) adverse findings that suggest unsafe product might be in
    the market must be reported promptly to FDA; and (4) FDA would retain
    the discretion to inspect plants that had been subject to a third-party
    audit.

        Question 9. Given finite resources and the many millions of
    imported food shipments from thousands of foreign sources, how can FDA
    provide sufficient oversight to assure American consumers that imported
    foods are safe?
        Answer 9. As with domestically-produced food, Congress needs to
    provide FDA with a modern mandate for oversight of imports that is
    commensurate with the globalization of the food supply. Specifically,
    Congress should make the U.S.-based importer or other responsible
    entity accountable for ensuring that the imported food has been
    produced in accordance with U.S.-food safety standards, including
    applicable preventive process controls. This approach calls upon
    importers to manage their supply chains responsibly and, as a condition
    of entry of food into the United States, be able to document that
    imported food was produced under conditions that make it safe. Though
    this approach relies on the food industry meeting its food safety
    responsibilities, it requires meaningful government oversight to be
    effective and credible. Some of this could come by enhancing FDA's
    authority and resources to inspect overseas and to work with foreign
    governments to leverage their food safety oversight capacity. In
    addition, imports may be particularly amenable to third-party audits as
    a complement to government inspection. Importers with well-documented
    systems for ensuring the safety of their products that are verified
    regularly by independent, credible auditors could be given fast track
    entry into the United States.
                          questions of senator harkin
        Question 1. I agree with your emphasis on prevention of food-borne
    illness as presented in your testimony. However, to focus on
    prevention, we must act in a coordinated manner across all government
    agencies that play a role in ensuring the safety of our Nation's food
    supply.
        Please describe the steps that FDA, USDA, and other agencies with
    responsibility over food safety can take to coordinate programs and,
    more importantly, integrate their missions, in order to focus on
    prevention, intervention, and response as called for in the FDA Food
    Protection Plan.
        Answer 1. The Federal Government's many food safety agencies cannot
    effectively coordinate their programs, integrate their missions, and be
    more preventive under the current structure of the system, which is
    prescribed by law. Certainly, there has been coordination in certain
    focused areas, such as among CDC, FDA and USDA's Food Safety and
    Inspection Service on food-borne illness surveillance and outbreak
    investigations. With respect to integrating their core food safety
    programs, however, the agencies are hamstrung. This is most evident in
    the case of FSIS, which gets two-thirds of Federal food safety
    resources to carry out a statutorily required but obsolete form of
    inspection in the Nation's meat and poultry plants. FSIS is required by
    law to use nearly all of its resources for this purpose, rather than
    for collaborating with FDA on integrated preventive strategies, and
    FSIS is even precluded by law from working with FDA on the farm to
    address pathogens such as E. coli O157:H7 and Salmonella, which often
    originate on the farm but then affect meat and poultry and FDA-
    regulated products, such as fresh produce. The only substantial and
    lasting solution to the lack of integrated effort across the Nation's
    food safety system is legislative change. Congress should modernize the
    food safety laws to make prevention the central responsibility and to
    create a unified organizational structure with clear accountability for
    mounting integrated, prevention-oriented efforts to reduce foodborne
    illness.
                           questions of senator enzi
        Question 1. You talk about performance standards, and I think this
    makes a lot of sense. One thing I worry about, though, is a
    proliferation of dozens or even hundreds of performance standards and
    how businesses, especially small businesses, can stay on top of it. We
    don't want to take all the innovation and flexibility out of the
    system. How do we make sure we have the standards we need, without
    getting too far down in the weeds?
        Answer 1. Performance standards should focus on significant hazards
    where an objective measure of performance can make a clear contribution
    to food safety. The number of such hazards in any operation is
    typically small and thus any given business should have a fairly small
    number of standards to keep up with. In addition, proper performance
    standards are inherently flexible and should promote innovation. For
    example, rather than telling a company the exact time and temperature
    it should achieve in cooking a ready-to-eat food (a so-called ``command
    and control'' approach), it should specify the amount of pathogen kill
    required to produce a safe food and leave it to the innovation of the
    company to adopt the cooking process that works best for its products
    in its operation. In this way, the government sets the food safety
    goal, on behalf of the public, and the company is free to choose how
    best to achieve the standard.

        Question 2. You object to the standard in the Food Protection Plan
    for FDA imposing preventive controls of a food associated with
    ``repeated serious adverse health consequences or death.'' Other than
    the use of the word ``repeated'' isn't that basically the standard for
    a Class I recall? We have to set priorities somehow--why isn't this
    standard good enough? What should the standard be?
        Answer 2. My most fundamental objection to the approach in the FDA
    Food Protection Plan is that it relies on FDA rulemaking to establish
    requirements for preventive process control on a case-by-case basis. I
    think we need a comprehensive, congressionally mandated shift to
    preventive controls, with FDA charged to implement the mandate in a
    reasonable, flexible way, including possibly exempting some categories
    of companies from the requirement. In short, based on all that the food
    industry and the food safety agencies have learned about the value of
    preventive controls, Congress should shift the presumption from one
    that says such controls are not required to one that says they are.
        While I do not think that the requirement of preventive controls
    should be left to case-by-case FDA rulemaking, if it is, the standard
    should be one that focuses on prevention, not the intensity of
    reaction. The classification of a recall as Class I determines not
    whether a product should be withdrawn but simply the intensiveness of
    the efforts a company must make to pull adulterated product from the
    market and confirm the effectiveness of the recall. It is appropriate
    that the most intensive efforts be reserved for cases in which there
    may be serious adverse health consequences. Products are also subject
    to a recall, however, if they ``may cause temporary or medically
    reversible adverse health consequences.'' Somewhat less intensive
    efforts may be justified to complete the recall of such products from
    the market, but we should still be seeking to prevent products posing
    such risks from entering the market in the first place through
    preventive controls. Otherwise, we would be failing to address the
    great majority of foodborne illness cases through preventive controls,
    which I believe would be bad for public health and public confidence in
    the food supply. This is why the Class I standard for intensity of
    reaction in a recall situation is not a good model for deciding when
    preventive controls are needed.
        Finally, I would note, as I did in my testimony, that the standard
    proposed in the Food Protection Plan is actually more restrictive of
    FDA's authority to require preventive controls than current law. Under
    current law, FDA has mandated HAACP (Hazard Analysis and Critical
    Control Points) based on the law's food adulteration provisions and the
    general authority the law gives FDA to issue regulations for ``the
    efficient enforcement of the Act.'' Under this standard, FDA can issue
    preventive control regulations based on a showing that they will guard
    against a reasonable possibility of injury to consumers. The last thing
    Congress should do is make the standard for preventive controls more
    restrictive at a time when many in industry, as well as the expert
    community, are calling for a shift to prevention as the key to an
    effective, credible food safety system.

        Question 3. You suggest unifying the food-related components of FDA
    into a single organization within HHS. I'm intrigued by this idea, as I
    think it avoids some of the pitfalls of ``single food agency''
    proposals, but I think it falls short on dealing with the fact that
    there are still 20 different agencies that have a piece of food safety.
    Do you believe a new organization split off from FDA would be better
    off in terms of making sense out of the fragmented jurisdiction? Why?
        Answer 3. I agree that bringing together all of the agencies that
    have a piece of food safety is the ideal solution and should remain a
    goal. I am convinced, however, that the right first step is to focus on
    FDA and on building within HHS a model food safety organization with
    the modern legislative mandate and other tools required to provide real
    leadership on food safety nationally and internationally. At some later
    time, if circumstances permit, the food safety functions of USDA could
    be folded into a fully unified Federal food safety agency.
        The new organization within HHS would be better off in its ability
    to lead on food safety because, first, the four major components of FDA
    with food safety responsibilities would be unified into a cohesive unit
    with accountable leadership, and second, the food safety function in
    HHS would be elevated within the department, thus enhancing the ability
    of the food safety leader to be heard and be impactful in the executive
    branch and in the world. Right now, the food function at FDA is
    fragmented and submerged. That has to change for FDA and HHS to be
    effective on food safety.
                           questions of senator burr
        Question 1. How can the current FDA retail food safety program be
    improved? What other actions can be taken to improve retail food
    safety?
        Answer 1. The key for FDA on retail is to build on and enhance its
    partnership with the States and localities. Congress should recognize
    in law the critical role of State and local agencies on retail food
    safety, and it should provide FDA with the mandate and the resources to
    foster wider adoption and effective implementation of the Food Code.
    There is also much opportunity for FDA to leverage State and local
    interest in retail food safety by providing training and other
    technical assistance.

        Question 2. Since you do not think FDA should be in charge of
    determining when preventive controls should be required, what does the
    new statutory prevention mandate for the FDA look like? What will the
    rules be for industry, both domestic and international, to follow?
        Answer 2. I think that Congress should establish by law the
    principle (or presumption) that all those who produce and sell food
    should have in place the basic preventive controls to make it safe.
    This should be in the form of a flexible mandate that recognizes the
    diversity of the food system from farm to retail and that authorizes
    FDA to tailor the requirement to the circumstances of particular
    sectors. The basic elements for both domestic and international
    producers include demonstrated adherence to basic sanitation
    procedures, awareness of the potential hazards in their operations, and
    effective measures in place and working to minimize those hazards in
    accordance with applicable food safety performance standards. This is
    mostly common sense and good management of a food operation and should
    be implemented with reasonableness so that the system is making a real
    contribution to food safety, not just satisfying a legal mandate.

        Question 3. Please explain in more detail your vision of FDA
    reorganization and what type of food safety position you want to be
    created.
        Answer 3. I think FDA should be divided into two agencies. One
    would manage FDA's drug, medical device and biologics functions. The
    other would manage all of FDA's food-related functions and would
    include the current Center for Food Safety and Applied Nutrition,
    Center for Veterinary Medicine, the food-related field resources from
    the Office of Regulatory Affairs, and the National Center for
    Toxicological Research. The unification of these components in a single
    agency would put all of the food safety resources and expertise under
    one official, who could then be held accountable for the success of the
    overall program. It is particularly important that the field force at
    FDA become an integral part of the public health-oriented prevention
    effort on food safety, with clear accountability to the food safety
    leader. This bifurcated FDA should take advantage of synergies and
    shared services to the extent possible.
        In addition to being unified, the food function should be elevated
    within HHS by making the leader of the food safety agency a
    presidential appointment, with a 7-year term, and reporting directly to
    the Secretary. The food safety leadership position should be
    accountable to the Secretary, the President and the Congress but be
    seen as a professional position that requires continuity to be
    successful.

        Question 4. What do you think about the Grocery Manufacturers
    Association's idea of expedited entry of foods that meet FDA's
    standards and conditions for expedited entry?
        Answer 4. I support the idea of expedited entry as an incentive for
    importers to more carefully manage their supply chains and to provide
    an extra measure of assurance that their products have been produced in
    accordance with U.S. standards.

        Question 5. I noticed you used to run the USDA Food Safety and
    Inspection Service in the 1990s. I'm interested in your perspective on
    the best way for us to ensure any food safety and defense legislation
    we enact reflects a comprehensive ``farm-to-fork'' strategy. We cannot
    forget the farm portion of this equation--for both produce and animal
    agriculture. What is your advice to us in this regard?
        Answer 5. The food safety challenges at the farm level are diverse
    and difficult. Approaches that work in processing plants may not work
    well on the farm. Nevertheless, production agriculture is properly just
    as much a part of the food safety system as any processor or retailer,
    and ways need to be found to set and enforce standards for preventive
    controls or other interventions on the farm where they can make a real
    contribution to food safety. One example is the fresh produce sector.
    Another is the control of pathogens in animal production. The
    implementation of any new standards on the farm should be done in
    partnership with State and local agencies, including agriculture
    departments, that have working relationships with the farm sectors in
    their communities.
                          questions of senator allard
        Question 1. It is my understanding that during recent issues with
    the domestic food supply, including issues with spinach and peanut
    butter, the industry was willing and cooperative in working with FDA to
    institute a recall. How would additional enforcement authority have
    changed this scenario?
        Answer 1. Most recalls are conducted voluntarily, and any mandatory
    recall authority should be structured so that it does not undercut
    incentives for companies to cooperate on voluntary recalls. FDA and
    USDA should, however, have authority to mandate a recall when a company
    does not cooperate or when a mandatory recall is the best way to
    protect public health in an emergency situation. I do not know enough
    about the details of the spinach and peanut butter cases to comment on
    them specifically.

        Question 2. In your opinion what can be done to further educate the
    public, private sector and interested government agencies on food
    safety, recalls, etc.''
        Answer 2. I think the basics of food safety and how consumers can
    protect themselves should be built into every elementary school
    curriculum. With regard to broader public and industry education, no
    agency has a clear mandate or significant resources for this purpose.
    Without those tools, there is little the agencies can do. I think the
    collaborative efforts on food safety education going on between
    government and industry through the Partnership for Food Safety
    Education have the right idea but lack the resources to achieve the
    scale and reach needed to make a difference.

        Question 3. Do you think that further education should play a role
    in addressing food safety? Do you have a single suggestion to further
    education and the distribution of informative resources regarding food
    safety?
        Answer 3. I think food safety education has a critical role to
    play. Consumers have the right to expect that everyone involved in
    producing and marketing food has done everything reasonably possible to
    make it safe, but consumers still need to know and observe safe food
    handling practices. I think educating kids from a young age as part of
    their elementary education is the place to start.
       Response to Questions of Senators Kennedy, Enzi, Burr, and Allard
                               by J. Joseph Corby
                          questions of senator kennedy
        Question 1. A significant impediment to the FDA doing a better job
    on food safety is its serious lack of adequate resources. I believe the
    President should propose a substantial increase in FDA's budget and the
    Congress should increase appropriated funds to the FDA. Assuming that
    won't happen, or that increases won't be sufficient, I'd like you to
    comment on some ways to leverage FDA resources:

         a third party program for inspection and laboratory
    testing,
         fees on the food industry, such as an annual registration
    fee, and
         enhanced collaborations with States and localities.

        Answer 1. Even if there were a substantial increase in resources
    and funding for FDA, the majority of food safety efforts in this
    country would still be performed by the States and local government
    agencies. What FDA must do, and do now, is adopt strategies for
    incorporating State and local government food safety efforts into a
    national food safety and defense plan. This is something FDA has
    recognized for years, but has failed to accomplish. FDA must leverage
    third parties and government entities for inspection and lab testing in
    order to meet today's food safety demands.
        Third party inspection and lab testing at foreign manufacturing
    plants is a logical step for assisting FDA with imported products.
    State and local governments can very capably handle much of the
    domestic inspection and lab testing that is needed. FDA should not be
    eliminated from domestic food safety work, but a more collaborative and
    coordinated effort could be established with State and local agencies
    in a more strategic fashion. The Manufactured Foods Regulatory Program
    Standards [MFRPS], when fully implemented, will ensure State and local
    agencies are performing at a nationally recognized performance
    standard.
        Most States and local agencies do assess fees to food
    establishments by way of licenses or permits. These can be used as an
    administrative enforcement mechanism, allowing State and local agencies
    to revoke a license or permit for firms that fail to follow food safety
    standards. Registration fees, on the other hand, are generally employed
    for raising income and do not carry the administrative clout a license
    or permit has. These fees, whether a license, permit, or registration,
    can provide necessary funding for government agencies to carry out
    needed food safety control functions.
        Enhanced collaboration with State and local government agencies by
    FDA will never be accomplished until FDA begins to accept State and
    local inspection results and laboratory analytical work. Although FDA
    encourages States to enter their lab results into a data system called
    Elexnet, they do not use those laboratory results to initiate
    enforcement action. Some State laboratories, including New York's, are
    part of FDA's Food Emergency Response Network [FERN] and FDA will
    accept the test results of those laboratories for specific, FERN-
    related activities. However, the routine analytical work on foods
    performed by these same food labs is not accepted. If FDA were to
    accept analytical work from State and local government labs and act on
    that data, there would be an immediate impact on food safety. New
    York's recalls of imported foods is one example. A total of 1,469
    recalls of imported products from 61 countries were coordinated by New
    York officials since 2002, and that information, including relevant lab
    analysis, was shared with FDA. FDA Import alerts were only issued on
    these products after FDA collected an additional sample of the recalled
    product for their own individual testing. To date, FDA has issued only
    13 import alerts from the 1,469 imported food recalls coordinated by
    New York State.

        Question 2. Mr. Taylor talked about food safety from farm-to-table.
    Ms. Smith DeWaal talked about food safety on farms, and Mr. Dooley
    mentioned good agricultural practices for produce. Traditionally, the
    FDA doesn't play a huge role on farms or at retail establishments. Do
    you have some suggestions about how we could enhance FDA's role there
    without raising the obvious sensitivities? What role can the States
    play?
        Answer 2. States are already active at the producer level and FDA
    must begin to leverage this work. State officials in California have
    mandated a better practices program for leafy vegetable growers. State
    officials in Florida and Virginia are active in mandating similar
    efforts for tomato producers. Many other States, including New York,
    have developed their own Good Agricultural Practices [GAPs]
    certification programs and have made them available to fruit and
    vegetable growers. These GAPs certifications are conducted annually by
    States and have been used effectively by fruit and vegetable growers to
    enhance their markets. The private sector also has a number of GAPs
    certification entities.

        Question 3. Mr. Corby, you describe how the FDA won't use test
    results or other information generated by the States. It makes sense to
    me that there could be considerable gains in efficiency if FDA were to
    accept such information. Would New York State, and, if you can answer,
    other States, be willing to work with the FDA to address any concerns
    it may have about information generated by the States, to make this
    happen?
        Answer 3. The considerable gains you mention could be accomplished
    immediately. Consider that more than half of the inspections of food
    establishments reported annually by FDA were inspections performed by
    States under contract with FDA. Why FDA will not accept all the other
    inspections performed by the States in other food firms remains a
    mystery to State food safety program managers. Also, food firms that
    FDA may inspect once every 5 years or more are inspected annually by
    the States and, in many cases, multiple times each year. All of the
    States would likely be willing to work with FDA to develop a strategic
    inspection plan that would coordinate efforts and avoid duplication.
    Not all the collaborative efforts that could be accomplished would
    require additional funding. FDA should, however, consider a better
    funding system for the States than is currently utilized. USDA/FSIS is
    budgeted funds specifically for working with the States. FDA needs a
    similar line item in their budget for this purpose.
                           questions of senator enzi
        Question 1. I like your idea of one food system. However, I don't
    think one food agency is the way to one food system. How do we get to
    one food safety system?
        Answer 1. I believe a ``single food safety policy'' is what is
    needed. Whether there is one agency or a multitude of agencies at the
    Federal level, the States and local agencies will still perform the
    bulk of the work. In the later part of 1990, an effort called the
    National Food Safety System [NFSS] was put together and a number of
    collaborative Federal/State efforts were developed which are still in
    existence today. An alliance of food safety stakeholders should be
    organized to identify foundations for re-establishing an integrated
    food safety system for this country. There is currently an effort to do
    this through George Washington University, the Association of Food &
    Drug Officials [AFDO], and other organizations.

        Question 2. How can we ensure that Federal food safety efforts
    effectively leverage State and local activities? Your State has done so
    through partnership agreements, but it seems that these have to be
    executed State by State. Is there any way to do it more efficiently,
    perhaps on a regional scale?
        Answer 2. For inspection purposes, the Manufactured Food Regulatory
    Program Standards [MFRPS] is a great place to begin. Once State and
    local agencies verify that they meet the recognized program standards,
    FDA should begin to offer these States more inspection contract work.
    This added contract funding will provide States the motivation for
    complying with the MFRPS and thereby qualify for additional funds, to
    enhance the States' food safety programs. Most States will likely be
    very anxious to participate.
        An effort to leverage laboratory analytical work conducted by
    States and local agencies is currently underway by FDA. This is a
    critical piece for FDA and may require lab certification and methods
    verification, all of which is currently supported by the States.
        It is true that most collaborative Federal/State efforts today are
    produced on a State-by-State basis. There are, however, a number of
    successful existing partnership models that could be promoted and
    applied nationally or regionally. Two of the more popular ones are the
    Integrated Food Safety Partnership (model for State and FDA District)
    and the Import Collaborative Project (New York and Texas). These
    agreements are designed to produce a seamless system that is crucial
    for enhancing a food safety program.

        Question 3. When you share information with FDA, where does it go?
    Do you think it just gets archived into a big database, or do you
    believe this vital intelligence is acted upon?
        Answer 3. We share information with the FDA District Office in
    Jamaica, New York or the Upstate Import Office in Buffalo, New York.
    This data and information can be transmitted from there to any FDA
    office or Center. Unfortunately, the majority of this data is not
    utilized.
                           questions of senator burr
        Question 1. How many States have similar food safety partnerships
    and/or import initiatives with the FDA offices in their States?
        Answer 1. Texas has recently begun an imported food program modeled
    after what New York has been doing, while Michigan and Oregon have
    asked for our assistance in developing import programs there.

        Question 2. What have been the biggest hurdles in working with the
    FDA on those initiatives?
        Answer 2. The biggest hurdle has been the laboratory issue. As
    mentioned above, New York coordinated 1,469 food recalls of imported
    foods from 61 countries, providing FDA with the analytical evidence
    that the products were adulterated. FDA would only issue import alerts
    after they had completed their own lab testing. More frustrating was
    the fact that only 13 import alerts were accomplished for the 1,469
    recalls because of FDA's lack of resources.

        Question 3. I have heard about a new initiative, called FoodSHIELD,
    which the Association of Food and Drug Officials is supporting along
    with the DHS National Center for Food Protection and Defense and USDA.
    I understand this system is supposed to support Federal, State, and
    local government agencies, labs, and emergency responders in defending
    the food supply through web-based tools. What are the benefits of
    FoodSHIELD, and how can we support this innovative approach? In
    addition, what is the status of the FoodSHIELD databases that will
    profile the infrastructure responsible for protecting and defending the
    food supply?
        Answer 3. FoodSHIELD is a sophisticated web-based platform that
    facilitates communication, coordination, education and training among
    the diverse communities that make up the Nation's food and agriculture
    sectors. It is sponsored by the National Center for Food Protection and
    Defense [NCFPD] in partnership with the Association of Food & Drug
    Officials. Two major components of FoodSHIELD are ``LABDIR,'' a
    database that captures the national lab infrastructure, and
    ``Food&AgDIR,'' the counterpart for Federal, State, and local food
    safety and defense programs. A few of the benefits of FoodSHIELD are as
    follows:

         Provides contact information for food protection and
    defense individuals across the Nation at the Federal, State, and local
    government levels;
         Profiles all agencies responsible for food protection and
    defense efforts from ``farm to fork'';
         Illustrates the enormity of food protection and defense
    efforts accomplished at the State and local levels by providing
    specific data on inspections and investigations conducted at that
    level;
         Collects information from food laboratories relative to
    accreditation, analytes, equipment, and expertise;
         Allows agencies to gauge their program performance against
    others through the use of Query tools;
         Allows individuals to quickly obtain emergency contact
    information for State and local governments; and
         Expansion of FoodSHIELD will include similar available
    information from industry.

        There are currently about 28 States actively participating in
    FoodSHIELD and AFDO is obtaining commitments from the remaining States
    to get involved as well. Congress's support of FoodSHIELD would be most
    welcomed.
                          questions of senator allard
        Question 1. In your opinion what can be done to further educate the
    public, private sector and interested government agencies on food
    safety, recalls, etc.''
        Answer 1. We need a comprehensive education and risk communication
    system. Education should be a partnership between government, industry,
    and academia to provide consumers with instant food safety information
    concerning recalled products and illness issues. There have been a
    number of real successes associated with the formation of stakeholder
    alliances that were established to promote food safety education or to
    advance HACCP principles within a specific food industry (ie., Seafood
    HACCP Alliance). Stakeholders need to coordinate their education
    programs and messages, and this could be accomplished through a
    stakeholder's alliance. Product recalls must become better coordinated
    as well. State and local governments are much closer to industry and
    consumers than Federal agencies, and they can better provide
    information to small businesses, non-English speaking entities, and
    specialized food establishments such as food banks, food pantries, and
    institutions.

        Question 2. Do you think that further education should play a role
    in addressing food safety? Do you have a single suggestion to further
    education and the distribution of informative resources regarding food
    safety?
        Answer 2. Yes, education plays a very important role. Small
    businesses are in greatest need of education and State and local
    regulatory agencies have begun to target these establishments through
    food safety education requirements that include management
    certification and recertification. There is also food safety programs
    provided to small businesses specifically designed to assist them in
    gaining compliance with State requirements. We do this in New York and
    find that 75 percent of the firms provided specific educational
    guidance will gain compliance and pass their next inspection. We
    believe that education has become an effective enforcement and
    compliance tool. Multi-language materials and ethnic-specific
    programming is best coordinated at the State or local level for the
    reason mentioned in Question 1.
       Response to Questions of Senators Kennedy, Enzi, Burr and Allard
                             by the Hon. Cal Dooley
                          questions of senator kennedy
        Question 1. There's a lot of real value in the Food Protection
    Plan, however, one thing that concerns me is that the plan proposes
    allowing the agency to require process controls for a food, but only
    after the food is associated with repeated instances of serious adverse
    health consequences or death. Why should the FDA have to wait for
    children or the elderly to die or be seriously injured by a food before
    companies making it are required to make it safely?
        Answer 1. The responsibility to produce safe food must, in the
    first instance, rest with the food industry. Food companies are in the
    best position to understand and evaluate the potential risks associated
    with the production of different types of foods and to evaluate the
    preventive controls that might reasonably address those risks. The
    Secretary should thus have limited authority to require specific
    preventive controls when there is a risk of severe health consequences.
    The effectiveness and ongoing necessity of controls required under such
    emergency circumstances should be periodically reviewed by FDA.

        Question 2. A significant impediment to the FDA doing a better job
    on food safety is its serious lack of adequate resources. I believe the
    President should propose a substantial increase in FDA's budget and the
    Congress should increase appropriated funds to the FDA. Assuming that
    won't happen, or that increases won't be sufficient, I'd like you to
    comment on some ways to leverage FDA resources:

         a third party program for inspection and laboratory
    testing;
         fees on the food industry, such as an annual registration
    fee; and
         enhanced collaborations with States and localities.

        Answer 2. Greater consideration of how third party inspectors,
    auditors and laboratories can effectively supplement existing FDA
    resources should be the focus of the committee's deliberations, and
    greater collaboration between local, State and Federal agencies should
    be encouraged. However, food imports and facilities should not be taxed
    to provide benefits that accrue to the public, such as the cost of
    science and inspections. Fees are appropriate when the benefit of a fee
    flows to the food industry. The benefits of science and inspections
    flow to the public generally, not to the food industry.

        Question 3. I understand that many in the food industry are
    implementing process controls to assure the safety of the foods they
    make, and they also expect their suppliers to have such controls in
    place. These sorts of voluntary programs are of course beneficial, but
    they don't help for those who don't voluntarily comply. Shouldn't every
    company have a plan to make its food safe, as Mr. Taylor and Ms. Smith
    DeWaal have testified?
        Answer 3. Food companies are subject to a longstanding legal
    requirement to produce food that is not adulterated. All food companies
    are now required by regulation to implement a variety of preventive
    controls. What's more, food companies routinely identify and evaluate
    food safety hazards, implement additional preventive controls, and
    employ systems to ensure the effectiveness of preventive controls. FDA
    has ample current authority to intervene with food companies that do
    not adhere to these existing legal requirements.

        Question 4. What can the HELP Committee, which is an authorizing
    committee and not the Appropriations Committee, do to increase the
    frequency with which food facilities are inspected?
        Answer 4. Thanks to the leadership of Senator Kennedy, FDA food-
    related spending for fiscal year 2008 enjoyed an increase. What's more,
    Secretary Leavitt has pledged to seek a substantial increase for FDA
    food-related spending in the fiscal year 2009 budget request. We are
    eager to work with Senator Kennedy, other members of the HELP
    Committee, and with our partners in the Alliance for a Stronger FDA to
    ensure that appropriators recognize the critical importance of funding
    for FDA food-related activities. FDA should partner with other Federal
    agencies and with State and local officials to maximize the
    effectiveness and reach of various food facility inspections so that,
    using a risk-based system, facilities can be inspected at an
    appropriate frequency.

        Question 5. Mr. Taylor talked about food safety from farm to table.
    Ms. Smith DeWaal talked about food safety on farms, and you mentioned
    good agricultural practices for produce. Traditionally, the FDA doesn't
    play a huge role on farms or at retail establishments. Do you have some
    suggestions about how we could enhance FDA's role there without raising
    the obvious sensitivities? What role can the States play?
        Answer 5. We support the creation of scientifically based and
    enforceable produce safety standards. Although produce safety standards
    should be set nationally, FDA should be directed to partner with those
    State agencies designated by each governor (State agriculture
    commissioners, for example) to facilitate compliance and to ensure that
    unique local conditions are properly addressed.

        Question 6. You testified against user fees. I believe that an
    inadequately resourced FDA is a liability for the food industry, and
    also for consumers and the public health. Do you agree, and if not, why
    not? If you do agree, and we assume for the sake of argument that FDA
    does not receive adequate increased appropriations, doesn't it become
    imperative for the food industry to support some form of user fees?
        Answer 6. FDA is an essential and important partner for the food
    industry and needs additional resources to fulfill its mission of
    ensuring food safety. As I noted earlier, we are confident that
    Congress and the Administration share our desire to increase FDA
    spending and we oppose taxes or fee on food imports or facilities. As
    you know, a user fee is appropriate when the benefits of the government
    service flow to an individual or to a particular business. In this
    case, the benefits of inspections, science-based standards, and
    enforcement activities flow to all Americans, not simply to food
    companies. What's more, food taxes or fees will fall unequally on some
    companies and some consumers. Increasing food taxes at a time when food
    prices are rising faster than inflation (due, in large measure, to the
    expansion of the Federal ethanol mandate) would negatively impact many
    Americans. The potential difficulties in obtaining sufficient
    appropriated funds should not be an excuse to impose a new tax on the
    food industry.
                           questions of senator enzi
        Question 1. You support mandatory recall, but only when a company
    has refused to conduct a voluntary recall. What about where the company
    is conducting the recall, but dragging their feet about it? Should FDA
    be able to order them to conduct the recall on a certain timetable?
        Answer 1. Yes. Foods that present the risk of serious adverse
    health consequences or death should be removed from the marketplace as
    fast as possible. We think that the recall system will work best when
    companies have the initial opportunity to conduct a recall. FDA should
    have the authority to order a recall if a company declines to undertake
    one and to monitor the effectiveness of recalls and to be able to
    intervene if a recall is undertaken but not implemented effectively.

        Question 2. Prior to this year, no one would have thought that pet
    food was risky, but then there was a huge problem with melamine
    contamination. We can definitely do better on food safety, but we will
    someday be taken by surprise. How do you determine which products pose
    ``no meaningful risk?''
        Answer 2. Theoretically, any food can present a meaningful risk
    with respect to intentional contamination. But the vast majority of
    foodborne illness is due to inadequate controls over naturally
    occurring hazards, not to intentional contamination. By knowing the
    hazards associated with specific products, by using good food-borne
    illness attribution data, and by understanding the processes used in
    production of a food and the controls applied in addressing the
    hazards, it is possible to determine which products pose the greatest
    risk to consumers.

        Question 3. FDA is woefully underfunded and understaffed. I am
    concerned that even with sufficient funds, there might not be
    sufficient personnel to fill the jobs, given the technical expertise
    required. You support capacity-building abroad, which is great, but
    what about capacity building here at home?
        Answer 3. As a member of the Alliance for a Stronger FDA, we
    strongly support greater funding for FDA. In particular, we have urged
    Congress and the Administration to double FDA spending over 5 years.
                           questions of senator burr
        Question 1. Mr. Taylor believes that the FDA should be given a new
    statutory prevention mandate that, through regulation, will outline
    specific standards the food industry needs to meet. It sounds like you
    agree with him. Is that correct?
        Answer 1. We support making the prevention of contamination the
    primary focus of FDA's food-related activities. GMA believes the focus
    of our food safety efforts should be on the prevention of
    contamination. By constantly identifying and addressing the sources of
    contamination throughout each product's life cycle, we continually
    reduce the risk of food-borne illness to consumers. All food companies
    are now required by regulation to implement a variety of preventive
    controls. In addition, food companies routinely implement additional
    preventive controls to address additional risks posed by specific
    products.

        Question 2. The drug and device industries pay FDA user fees for a
    set of FDA performance goals agreed to by industry and the FDA. If
    Congress changes FDA's statute on food safety and requires the FDA to
    be much more aggressive on the prevention side, I could envision a
    similar user fee and performance goal agreement being worked out
    between FDA and the food industry. Would you still consider that to be
    a tax?
        Answer 2. Yes. FDA is an important and essential partner of the
    food industry, and we work with FDA to continually identify and prevent
    risks to public health. Expanding FDA's ability to develop science-
    based standards and new preventive controls benefits all consumers, not
    simply food companies. The performance goals in the drug and device
    context are fundamentally different from those that might be
    implemented on the food side. Drug and device companies are principal
    beneficiaries of the additional FDA staffing that the user fees provide
    while the public would be the principal beneficiaries of any fees
    imposed on the food side.
                          questions of senator allard
        Question 1. In your opinion what can be done to further educate the
    public, private sector and interested government agencies on food
    safety, recalls, etc.''
        Answer 1. Greater resources for FDA as well as greater
    collaboration between Federal, State, and local agencies are critically
    needed to improve food safety education.

        Question 2. Do you think that further education should play a role
    in addressing food safety? Do you have a single suggestion to further
    education and the distribution of informative resources regarding food
    safety?
        Answer 2. Public education is among the most effective tools
    available to address the threat of food-borne illness. Public agencies
    and the private sector are investing significant resources in efforts
    to promote food safety education. This begins with food safety
    education in elementary schools, but it requires reinforcement in later
    years as well. We need to be more innovative in how we approach this,
    with messages being delivered through print, broadcast, and electronic
    media.
     Response to Questions of Senators Kennedy, Harkin, Enzi and Allard by
                             Caroline Smith DeWaal
                          questions of senator kennedy
        Question 1. There's a lot of real value in the Food Action Plan,
    however, one thing that concerns me is that the plan proposes allowing
    the agency to require process controls for a food, but only after the
    food is associated with repeated instances of serious adverse health
    consequences or death. Why should the FDA have to wait for children or
    the elderly to die or be seriously injured by a food before companies
    making it are required to make it safely?
        Answer 1. Process controls should be applied to all food production
    and not limited only to those foods with a history of causing
    ``repeated instances of serious health problems or death to humans or
    animals,'' as called for in the Food Protection Plan. CSPI endorses
    legislation that would require all food establishments to implement
    process controls that meet performance standards designed to protect
    the public from foodborne illnesses.
        I am especially concerned about the standard set forth in the Food
    Protection Plan, as neither peanut butter nor spinach production would
    be subject to process controls. Yet our experience of the last 2 years
    has shown that these products could clearly benefit from such a system.
    A single outbreak of Salmonella in Tennessee in peanut butter sickened
    628 people in 47 States in 2007 and a single outbreak of E. coli
    0157:H7 on spinach caused 205 illnesses and killed three in 2006. The
    peanut butter outbreak was linked to unsanitary conditions and a leaky
    roof, while the spinach outbreak was linked to inadequate controls to
    stop contamination from a nearby pasture. In both cases, simple process
    controls implemented and regularly monitored in the plant or on the
    farm may have prevented the outbreak. However, the standard in the Food
    Protection Plan could conceivably require FDA to wait for multiple or
    ``repeated'' instances of serious health problems or death before
    requiring process controls. Prior to the 2007 outbreak, peanut butter
    had been related to only three outbreaks since 1990 and prior to 2006,
    spinach to only two.\1\
        Requiring a history of repeated outbreaks is also inconsistent with
    other instances where Congress has imposed safety requirements on the
    food industry based on the prospect of harm, rather than the proof of
    harm. For example, the Bioterrorism Act's traceability requirement at
    21 U.S.C. 350c(b) is based on the need to identify whether a food
    ``presents a threat of serious adverse health consequences or death to
    humans and pets'' and uses a ``reasonable belief '' standard to trigger
    its record access provisions. 21 U.S.C. 350c(a).
        It is likely a reactive standard will prove inadequate for
    preventing outbreaks and FDA would have to return to Congress for
    authority to require process controls based on more proactive criteria.

        Question 2. A significant impediment to the FDA doing a better job
    on food safety is its serious lack of adequate resources. I believe the
    President should propose a substantial increase in FDA's budget and the
    Congress should increase appropriated funds to the FDA. Assuming that
    won't happen, or that increases won't be sufficient, I'd like you to
    comment on some ways to leverage FDA resources:

         a third party program for inspection and laboratory
    testing;
         fees on the food industry, such as an annual registration
    fee; and
         enhanced collaborations with States and localities.

        Answer 2. The solution to inadequate resources at FDA is for the
    President to propose and Congress to enact a budget adequate to support
    FDA's responsibilities. Inadequate resources impose a significant risk
    to public safety.\2\ The Coalition for a Stronger FDA estimated FDA
    needs for fiscal year 2008 at several hundred million dollars \3\ above
    fiscal year 2007 funding just to carry out its current food safety
    mission. The FDA Science Board identifies a need for an additional $390
    million at CFSAN and ORA to implement a new food import system,
    modernize and implement safety standards for fresh produce, and improve
    laboratories.\4\ This does not include funds needed for CVM to
    modernize FDA's regulation of animal-derived products.\5\ The Action
    Plan for Import Safety also highlights the need for additional
    resources to implement its recommendations.\6\
        The FDA's Food Protection Plan attempts to sidestep the growing
    evidence of an agency that is underfunded by proposing leveraging third
    party inspections, imposing new fees and doing a better job of
    collaborating with State and local agencies. Fees proposed in the plan
    would raise about $26 million, which only offsets the costs of carrying
    out re-inspections of plants that fail an initial inspection and an
    export certificate program.
        Each bulleted proposal above has merits, but none provides a
    panacea for FDA's budget problems. And each will require start up costs
    to ensure that activities done using other entities have the requisite
    reliability, including training, accrediting, compensating and auditing
    the external government or third party inspectors to ensure plants meet
    Federal standards.
        Often these proposals are submitted as an alternative to increasing
    the funding for FDA. However, using third parties requires additional
    funding for certification and for State implementation. In fact, State
    and Federal agencies need compensation to conduct additional
    inspections, just as FDA would. Third party certification also would
    divert resources from FDA inspection to training, accrediting and
    auditing the third party organizations. Enhancing collaboration with
    State and local governments should be done. But it should be funded--
    otherwise FDA will have to divert scarce resources from their already
    anemic inspection program to an aggressive oversight program.
        CSPI supports funding food safety through the annual appropriation
    process, but if direct revenue sources must be found, then applying a
    general fee on foreign and domestic registrations under the
    Bioterrorism Act could generate significant funds. We prefer this
    approach to a fee-for-service system for food inspections, where
    inspectors may believe that they are working for the companies rather
    than the public. More than 332,000 food establishments have registered
    with FDA under the Bioterrorism Act. A registration fee of $1,000 could
    generate $332 million for food safety activities. CSPI would be happy
    to provide additional analysis of this concept.

        Question 3. Could you please your concerns, if any, with a
    voluntary approach to food safety?
        Answer 3. Much of the current FDA food safety program is voluntary.
    FDA lacks authority to require producers to recall tainted products,
    and instead relies on a voluntary system to take unsafe food off the
    market. FDA's infrequent inspections mean that food safety is largely
    managed through an industry honor system for food processors. Farmers
    are not required to follow the agency's good agricultural practices.
    These voluntary systems are failing to protect the public and industry
    as evidenced by the fact that outbreaks linked to FDA-regulated
    products are much more common then those linked to meat and poultry
    regulated by USDA. In fact, food regulated by FDA account for 66
    percent of all outbreaks of foodborne illness reported between 1990 and
    2005 \7\--more than twice the number of outbreaks attributed to food
    regulated by USDA.
        Voluntary programs implemented through marketing orders
    administered by USDA suffer additional defects. The programs are
    controlled by the growers or processors who are subject to economic
    pressures and who can terminate the order by majority vote if
    compliance becomes too burdensome. Since the standards are set by the
    industry, they may not represent good science and are frequently
    developed without balanced input from the public health community or
    from the consumers they are intended to protect. This often results in
    programs that implement the least burdensome standards possible because
    the focus is more on minimizing the impact on processors or producers
    than on protecting consumers. The public is also at risk since
    participants may vote to end the marketing order at any time and thus
    terminate whatever protections it provides with little notice to
    consumers.
        FDA's reliance on voluntary compliance with guidelines, education,
    and awareness proved ineffective in preventing foodborne illness from
    fresh produce. In 2006, CSPI called on FDA to enact a mandatory
    program, pointing out that the most important benefit of a mandatory
    program is that it would assure that both domestic and foreign growers
    and processors implement good agricultural practices. While many of the
    best growers and processors use HACCP-like systems and adhere to good
    agricultural practices, compliance is clearly not universal.\8\ It was
    estimated that California spinach growers lost approximately $350
    million in sales because of consumer reaction to the 2006 outbreak.\9\
        Voluntary government guidelines like the ones called for in the
    Four Pillars recommendations from GMA may be useful in helping industry
    identify its responsibilities, but cannot substitute for enforceable
    standards. In a voluntary system one bad actor can negate the efforts
    of responsible growers and food processors.\10\

        Question 4. You argued that every food company should have a plan
    to prevent food safety problems. Some would argue that such an approach
    is not risk-based, is over-regulatory, and will require companies to
    spend money for little gain in food safety. How would you respond to
    these concerns?
        Answer 4. If a company wants to prepare food and sell it to the
    public, it has the responsibility to show that it has evaluated food
    safety hazards associated with the products and processes, and has
    implemented systems that will eliminate or control those hazards.
    Otherwise all the risk of production is being borne by the consumer of
    the product, and consumers are in fact being used as the ``canaries in
    the coal mine.'' This is not acceptable, and many responsible companies
    have already implemented food safety plans throughout their productions
    systems.
        These food safety plans should form the basis for government
    inspection and provide the road map for evaluating systems failures
    whenever an outbreak or recall occurs. Risk should certainly be used to
    determine inspection frequency, but it should not be the factor that
    determines what foods are subject to process controls.
        Congress should enact food safety reform that places the primary
    responsibility for food safety on food establishments and gives the
    government sufficient authority to monitor and enforce this
    responsibility.\11\ Written HAACP or HAACP-like plans are required of
    all meat, poultry, seafood and juice manufacturers, and have proven
    effective in helping to control hazards in those products. These plans
    are also widely used by many individual companies where they are not
    currently required today. Process control plans can be incorporated
    into food production systems at all levels. Inspections and audits of
    the plans would ensure all food establishments are meeting safety
    standards--such as limits on the incidence or levels of contamination.
    Monitoring and enforcement of safety standards is a key element of
    inspection in a successful food safety program.
        The European Union has demonstrated that requiring process controls
    on all food establishments can be done without imposing too high a
    premium on individual companies. In the alternative, failing to
    implement process controls broadly will result in repeated instances of
    outbreaks imposing costs on the public and industry for healthcare
    services, litigation and lost confidence. These costs can be
    substantial. The Peter Pan peanut butter outbreak cost ConAgra more
    than $140 million, including $55 million in lost sales.\12\ Meanwhile
    foodborne illnesses from all sources impose a cost on consumers of
    billions of dollars annually.\13\

        Question 5. What can the HELP Committee, which is an authorizing
    committee and not the Appropriations Committee, do to increase the
    frequency with which food facilities are inspected?
        Answer 5. The problems with inadequate inspections of food are not
    limited to a lack of funding. The United States lacks a modern food
    safety oversight system, like those currently in use in the European
    Union and many other countries around the world. The failure to
    modernize our system is having real impacts--consumers worry that we
    have a ``third world'' food supply, and other countries are reluctant
    to import poorly regulated food products.
        The HELP Committee should develop and pass a modern food safety
    mandate for FDA-regulated food. It should contain the following
    elements:

        1. A National Food Safety Program that incorporates:

         Update registration of food establishments and foreign
    food establishments.\14\
         Process controls (including on-farm process controls) to
    reduce the adulteration of food products.
         Performance standards enforced by inspections.
         Importer accountability supported by certification of
    foreign countries' food safety systems and exporters.
         Federal and State cooperation.
         Mandatory traceback.
         A resource plan that describes funding needed to implement
    the national program.

        2. Research and Education

         Public health assessment system.
         Public education and advisory system.
         Research.

        3. Enforcement

         Food detention, seizure and condemnation.
         Notification and mandatory recall.
         Civil and criminal penalties.
         Citizen civil actions.
         Whistleblower protections.
         Administration and enforcement.

        4. Appropriations adequate to carry out these authorities

        Question 6. Mr. Taylor talked about food safety from farm-to-table.
    You talked about food safety on farms, and Mr. Dooley mentioned good
    agricultural practices for produce. Traditionally, the FDA doesn't play
    a huge role on farms or at retail establishments. Do you have some
    suggestions about how we could enhance FDA's role there without raising
    the obvious sensitivities? What role can the States play?
        Answer 6. The Fresh Produce Safety Act introduced by Senator Harkin
    offers a good starting point for improving safety on the farm. The bill
    establishes a national program for issuing good manufacturing practices
    for processors and good agricultural practices on the farm. Processors
    and growers would have to have written safety plans and keep records
    that can be inspected by the FDA. This is a good model for improving
    FDA oversight of on-farm safety.

        Question 7. 1 understand FDA now inspects food facilities on
    average every 10 years. I think it's unlikely that appropriated money
    will increase enough, or that a user fee program could raise enough
    money, to allow FDA to inspect every food facility annually or even
    every 2 years. So there might be some value in a third party inspection
    program, if companies were to participate in it. Would you support such
    a program? Under what conditions?
        Answer 7. As I noted above, FDA's Food Protection Plan attempts to
    sidestep the growing evidence of an agency that is underfunded by
    proposing leveraging third party inspections as a way of better
    allocating existing resources. The proposal has merits, but is not a
    panacea for FDA's budget problems. It will require start up costs to
    ensure that activities done using States or private entities have the
    requisite reliability. Mandating the use of third parties would also
    divert scarce agency resources from FDA inspection to training,
    accrediting and auditing the third party organizations. Therefore, the
    use of third parties should be seen as an alternative use of additional
    resources, not a substitute for new resources.
        With respect to States acting in place of FDA inspection, that
    system is already in place. Many inspections of FDA-regulated
    facilities are already conducted by State inspectors. For example, of
    17,730 FDA inspections conducted in 2006, more than half (9,164) were
    State contract or State partnership inspections.\15\ The problem with
    this approach is that State inspection programs are not consistently
    funded, and are often the victim of cuts when the State is facing a
    budget shortfall. Therefore, FDA needs the ability to monitor State
    inspections year-to-year, and step up Federal oversight whenever State
    inspections are cut. Otherwise, the programs will be highly variable
    and therefore less valuable in protecting consumers.
        With respect to third parties acting in place of FDA, this concept
    is controversial among many consumer organizations, who worry about the
    privatization of this important government service. At CSPI, we believe
    that there is a role for third party inspectors, so long as they have
    the same interests as the buying public in assuring the safety of the
    product. Thus, third party inspectors paid for by a retailer would be
    more trustworthy than one paid for by the company being inspected. It
    is also critical that these private entities are certified by FDA
    regularly, and that their inspections are regularly audited by FDA.
        The concept of ``nested audits'' is very useful in this context.
    One country I have visited used this very effectively in its seafood
    inspection program. Seafood companies each utilize a HACCP-based safety
    assurance program. This program is audited by a private auditor
    certified by the government. The plants are then regularly inspected by
    the government agency, with the inspection frequency based on the
    plant's performance during previous inspections. The agency can audit
    the work of the private auditor at the same time that it looks at the
    plant during the inspection. The government program is also subject to
    audit by countries that import fisheries products, which in this case
    included the governments of the European Union, Japan, and the United
    States. This type of ``nested audit'' provides a high degree of
    certainty that the audits are high quality, and that the standards for
    the audits are constantly being updated to meet international
    standards. It encompasses the concept of continuous improvement for all
    levels of the program.

        Question 8. What can you tell us about the food safety approaches
    of the European Union or other countries, including both domestically
    produced food and imported food, with a focus on how those approaches
    compare to that of the United States?
        Answer 8. The European Union (EU) has a much more modern system
    than the United States. Many of the national systems were modernized
    after the BSE (``mad cow'') crisis in Europe, with a move toward
    unifying food safety responsibility under a single agency in many
    countries. In addition, the national programs must implement standards
    adopted by the European Commission. The EU has also centralized risk
    assessment under the European Food Safety Authority, which has the
    ability to independently evaluate risks and communicate to consumers
    and the national governments, though it has no regulatory (risk
    management) responsibilities.
        The lessons learned in the EU can help guide our efforts to
    modernize food law in the United States. The EU's starting concept is
    that ``food policy must be built around high food safety standards,
    which serve to protect, and promote, the health of the consumer.'' \16\
    The European Commission's White Paper on Food Safety identified the
    following principles\17\:

         Food safety policy must be based on a comprehensive,
    integrated approach that covers the food chain from ``farm-to-fork.''
         Stakeholders' roles in the food chain must be clearly
    defined.

            1.  Food manufacturers and food operators have the primary
            responsibility for food safety;
            2.  Competent authorities monitor and enforce this
            responsibility; and
            3.  Consumers are responsible for proper storage, handling and
            cooking of food.

         Feed, food and their ingredients must be traceable through
    records kept by operators.
         The system needs to be flexible and reviewed to adapt to
    emerging risks and recognize new developments, while having a
    transparent approach to developing new policies.
         Risk analysis (which encompasses risk assessment, risk
    management and risk communication) should be the foundation for food
    safety policy.
         The science applied must meet the highest standards of
    independence, excellence and transparency. Where appropriate the
    precautionary principle should be applied in risk management decisions.

        There are additional sources of information to guide the committee
    as well. CSPI, working with the World Health Organization and the Food
    and Agricultural Organization of the United Nations, formed the Safe
    Food International project. In 2004, Safe Food International published
    guidelines in consultation with consumer organizations in developed and
    developing countries to assist both consumer organizations and national
    governments in focusing on the basic requirements for national food
    safety programs in their countries. I have attached a copy of the
    Guidelines.

        [Editor's Note: Due to the high cost of printing, previously
    published materials are not reprinted. For the Guidelines, please see
    http://www.safefoodinternational.org/
    guidelines_for_consumer_organizations
    .pdf.]
                          questions of senator harkin
        Question 1. I agree with your emphasis on prevention of foodborne
    illness as presented in your testimony. However, to focus on
    prevention, we must act in a coordinated manner across all government
    agencies that play a role in ensuring the safety of our Nation's food
    supply.
        Please describe the steps that FDA, USDA, and other agencies with
    responsibility over food safety can take to coordinate programs and,
    more importantly, integrate their missions, in order to focus on
    prevention, intervention, and response as called for in the FDA Food
    Protection Plan.
        Answer 1. FDA and USDA have had almost 100 years to coordinate
    their programs and integrate missions without making much progress. We
    still have USDA and FDA personnel inspecting imports side-by-side, and
    food plants that are subject to dual regulation. It would be a mistake
    to attempt to patch this system one more time by establishing an
    interagency authority or attempting to legislate cooperation between
    two separate food regulators.
        We believe the best approach would be to form a unified food safety
    administration in the United States, a step already taken in many other
    countries. The agency should be given a modern mandate, should be
    staffed from the existing food programs at FDA and USDA, and should use
    a budget that combines the resources of both these existing agencies.
    This approach has already been proposed by Senator Richard Durbin in
    the Safe Food Act of 2007, in response to a report of the National
    Academy of Sciences.
        The United States can learn from experiences in many other
    countries that have already created a single authority to manage food
    safety. In 2005, GAO reviewed programs in seven countries that have
    consolidated food safety activities under one agency and reported that
    officials and stakeholders consistently stated that doing so ``led to
    significant qualitative improvements in food safety operations that
    enhance effectiveness or efficiency.'' \18\ Among the advantages cited
    in the report are ``reduced overlap in inspections, more targeted
    inspections based on food safety risk, more consistent or timely
    enforcement of food safety laws and regulations, and greater clarity in
    responsibilities.'' \19\
        Short of this, Congress could require both agencies with regulatory
    responsibility over the food supply to take responsibility for the
    entire food supply and provide them each with authority to act whenever
    they see a problem. This would permit inspectors to work across
    jurisdictions. This would address the problems that exist with imported
    foods where USDA and FDA jurisdictions sometimes overlap, but resources
    are not shared. If Congress is not willing to truly modernize food
    safety systems, it should consider some new ``outside-of-the-box''
    approaches to improve the workings of the current system.
                           questions of senator enzi
        Question 1. Like many of us, you are concerned about FDA getting
    the resources needed to implement the Food Protection Plan. Do you have
    any sense of what level of funding it would take to turn things around?
    Your testimony indicated hundreds of millions of dollars, but can you
    be more specific?
        Answer 1. The FDA Alliance estimates FDA needs for fiscal year 2008
    are $140 million above fiscal year 2007 funding levels, recommending a
    budget of $597 million for food safety programs.\20\ The Coalition for
    a Stronger FDA last year began recommending an increase of $115 million
    for food safety programs at FDA but more recently raised its estimate
    to $250 million.\21\ The FDA Science Board identifies an additional
    $390 million needed to implement a new food import system, modernize
    safety standards for fresh produce and upgrade existing laboratories.
    This does not include funds needed for CVM to modernize FDA's
    regulation of animal-derived products.\22\ Based on these
    recommendations, anything short of $100 million in the fiscal year 2009
    budget will not be adequate to see real improvement in FDA's food
    program and the actual need is more in the range of $200 to $400
    million.

        Question 2. You represent consumers. How do we get them--and by
    ``them'' I mean all of us, since we are all consumers--to be better
    players in food safety? We could change many things, and send consumers
    much safer food, but they could still contaminate it at home. Other
    panelists talked about the farm end of the ``farm-to-fork'' continuum--
    what about the fork end?
        Answer 2. Educating consumers about safe food handling is a
    critical part of the food safety continuum. And it is not something
    that is done just once. Every year new scientific information is
    available, and consumers need to be reminded of the previous
    recommendations for keeping their food safe. CSPI joins with several of
    the government agencies that offer regular advice to the public on how
    to keep their food safe. We publish food safety advice in our Nutrition
    Action Health letter as well as on our Web site and in our media
    interviews. In fact, for over 5 years, the National Press Club invited
    me to hold a press conference right before Thanksgiving to remind
    consumers about safe handling, cooking and storage of holiday meals in
    their home kitchen.
        Another important approach is the use of safe handling labels on
    meat, poultry, eggs, and other raw food products that reminds consumers
    of the basic handling messages for consuming these products, as well as
    warning labels on unavoidable unsafe products, like raw shellfish
    harvested from certain regions, unless treated to control the hazards.
        In considering legislation, Congress should include a public
    education program, including labeling of raw and unsafe food products,
    and education of health professionals. Information provided to health
    professionals would improve diagnosis and treatment of foodborne
    illness. The Administration should be required to issue health
    advisories about foods that pose a threat to the public. However, this
    is not a substitute for improving the overall safety of the food
    consumers buy.
        Another issue to consider in legislation is the importance of
    managing risks in the restaurant and retail food sector. More than
    twice as many food-borne illness outbreaks occur from food prepared
    outside the home. Restaurants and food establishments accounted for 46
    percent of reported outbreaks between 1998 and 2004, according to data
    compiled by CSPI from CDC and State health department reports,\23\
    while home prepared foods accounted for 20 percent of outbreaks.

        Question 3. Given the number and incredible variety of FDA-
    regulated foods, do you think pre-market approval of foods by FDA is
    advisable or even possible?
        Answer 3. FDA has oversight of more than 136,000 registered
    domestic food facilities and there are approximately 189,000 registered
    foreign food facilities.\24\ For comparison, USDA, which conducts pre-
    market inspections, has responsibility for just 6,282 plants
    nationally.\25\ Pre-market approval for FDA-regulated foods would be
    costly and is not needed. Instead, Congress should enact laws to
    require food facilities to have in place industry specific food safety
    process control plans that are designed to meet federally established
    performance standards for safety. The plans should be subject to
    regular auditing by FDA during inspections, or using nested audits.
        The concept of ``nested audits'' is very useful in understanding
    how FDA might improve oversight. One country I have visited used this
    very effectively in its seafood inspection program. Seafood companies
    each utilize a HACCP-based safety assurance program. This program is
    audited by a private auditor certified by the government. The plants
    are then regularly inspected by the government agency, with the
    inspection frequency based on the plant's performance during previous
    inspections. The agency can audit the work of the private auditor at
    the same time that it looks at the plant during the inspection. The
    government program is also subject to audit by countries that import
    fisheries products, which in this case included the governments of the
    European Union, Japan, and the United States. This type of ``nested
    audit'' provides a high degree of certainty that the audits are high
    quality, and that the standards for the audits are constantly being
    updated to meet international standards. It encompasses the concept of
    continuous improvement for all levels of the program.
                          questions of senator allard
        Question 1. In your opinion what can be done to further educate the
    public, private sector and interested government agencies on food
    safety, recalls, etc.
        Answer 1. Educating consumers about safe food handling is a
    critical part of the food safety continuum. And it is not something
    that is done just once. Every year, new scientific information is
    available, and consumers need to be reminded of the previous
    recommendations for keeping their food safe.
        CSPI joins with several of the government agencies that offer
    regular advice to the public on how to keep their food safe. We publish
    food safety advice in our Nutrition Action Healthletter as well as on
    our Web site and in our media interviews. In fact, for over 5 years, as
    a public service, the National Press Club invited me to hold a press
    conference right before Thanksgiving to remind consumers about safe
    handling, cooking and storage of holiday meals in their home kitchen.
        Another important approach is the use of safe handling labels on
    meat, poultry, eggs, and other raw food products that reminds consumers
    of the basic handling messages for consuming these products, as well as
    warning labels on unavoidably unsafe products, like raw shellfish
    harvested from certain regions, unless they are treated to control the
    hazards.
        In considering legislation, Congress should include a public
    education program, including labeling of raw and unsafe food products,
    and education of health professionals. Information provided to health
    professionals would improve diagnosis and treatment of foodborne
    illness. The Administration should be required to issue health
    advisories about foods that pose a threat to the public. However, this
    is not a substitute for improving the overall safety of the food
    consumers buy.
        Another issue to consider in legislation is the importance of
    managing risks in the restaurant and retail food sector. More than
    twice as many food-borne illness outbreaks occur from food prepared
    outside the home. Restaurants and food establishments accounted for 46
    percent of reported outbreaks between 1998 and 2004, according to data
    compiled by CSPI from CDC and State health department reports,\26\
    while home prepared foods accounted for 20 percent of outbreaks.

        Question 2. Do you think that further education should play a role
    in addressing food safety? Do you have a single suggestion to further
    education and the distribution of informative resources regarding food
    safety?
        Answer 2. The biggest single impact for food safety education would
    be through proactive programs in the schools. Early education on safe
    food handling is essential to breaking down bad habits in the home--
    like failing to take precautions like hand washing or properly cooking
    food. Food safety information can easily be added to the science
    curriculum at almost every level, explaining not only what consumers
    should do, but why it is effective. School-based curriculums have many
    crossover effects to the general public. Educating children helps to
    impact their parents' behavior. Educating teenagers before they begin
    working in restaurants can avoid many mistakes.
        FDA has posted information specifically targeted for students and
    educators at http://www.cfsan.fda.gov/dms/educate.html. Additionally,
    the National Science Teachers and FDA have collaborated on a food
    safety curriculum with materials and training available to help science
    teachers teach about food safety posted at http:
    //www.foodsafety.gov/fsg/teach.html. These are good efforts that
    should be sustained and expanded but they have not and cannot close the
    loop on food safety.
        The home should be the final defense and not the front line in
    preventing foodborne disease. Our goal should be to provide safe and
    wholesome food to consumers, using preventive control programs at all
    levels. Private and public programs can then effectively arm consumers
    with information on how to recognize and avoid foodborne disease
    through safe food handling techniques.
                                   References
        1. Center for Science in the Public Interest, Outbreak Alert
    Database, http://www.cspinet.org/foodsafety/outbreak/pathogen.php. (The
    Outbreak Alert Database is maintained by the Center for Science in the
    Public Interest (CSPI). CSPI uses CDC data and other highly reliable
    sources to track food-borne illness outbreaks by food source. Its
    database contains over 5,000 outbreaks with both food and hazard
    identified spanning 1990 to 2005. A peer-reviewed article describing
    the database was recently published in Food Protection Trends. Caroline
    Smith DeWaal et al., Foods Associated with Food-borne Illness Outbreaks
    from 1990 through 2003, 26 Food Protection Trends 466, (2006).)
        2. FDA Science Board, FDA Science and Mission at Risk 2 (Nov.
    2007).
        3. FDA Science Board, supra at 56; Leslie Pray & Sally Robinson,
    Nat'l Academies of Science, Challenges for the FDA: The Future of Drug
    Safety, 18 n.5 (2007).
        4. FDA Science Board. supra at 53.
        5. Id.
        6. Interagency Working Group on Import Safety, Action Plan for
    Import Safety, Nov. 2007, 16.
        7. Center for Science in the Public Interest, Outbreak Alert!, Dec.
    2007, p. 5.
        8. Center for Science in the Public Interest, Citizen Petition,
    (Nov. 15, 2006) available at http://www.cspinet.org/new/pdf/
    fda_produce_petition.pdf.
        9. Elizabeth Weise & Julie Schmit, Spinach Recall: 5 Faces. 5
    Agonizing Deaths. 1 Year Later, USA Today, Sept. 20, 2007, available at
    http://www.usatoday.com/money/industries/food/2007-09-20-
    spinachmain_N.htm.
        10. See Renae Merle, After Last Year's E. Coli Outbreak, Produce
    Testing Diverged at the Border, Wash. Post, Oct. 12, 2007 (``Noting
    that the [voluntary Leafy Green Marketing Agreement] program touts 99
    percent of producers have signed up, [State Sen. Dean] Florez adds,
    ``It only takes 1 percent to poison an entire Nation.'').
        11. Compare Commission of the European Communities, White Paper on
    Food Safety, Jan. 12, 2000. 8. (. . . feed manufacturers, farmers and
    food operators have the primary responsibility for food safety;
    competent authorities monitor and enforce this responsibility through
    the operation of national surveillance and control systems . . .)
        12. Mike Hughlett, E. coli Outbreak Kills Meat Company: Huge Costs
    Seen in Fixing Problems, The Chicago Trib., para.19-11, Oct. 6, 2007,
    http://www.chicago
    tribune.com/features/lifestyle/health/
    chisat_toppsoct06,1,4231570.story.
        13. Ike Wilson, Local Farmers React to Proposed Food Safety Law,
    The Frederick News-Post Online, para.8, Oct. 5, 2007, http://
    www.fredericknewspost.com.
        14. Food facility registration passed in the Bioterrorism Act of
    2002.
        15. FDA, FY 2008 Congressional Justification for Food and Drug
    Administration: Food, at 29, http://www.fda.gov/oms/ofm/budget/2008/1-
    BudgetNarrative
    CFSAN.pdf.
        16. Comm. of the European Communities, White Paper on Food Safety,
    Jan. 12, 2000, 6. The White Paper on Food Safety provides the basis for
    establishing the European Union's food safety program.
        17. Id. at 8-9.
        18. Gov. Acct. Off. Rpt. No. GAO-05-212, Food Safety: Experiences
    of Seven Countries in Consolidating Their Food Safety Systems, Feb.
    2005, 4.
        19. Id.
        20. The shortfall in funding for FDA is described by Frank Claunts
    with the Office of Management at the Food and Drug Administration in a
    briefing ``FDA: Financial Realities'' in 2006. The charts from that
    briefing are available in the FDA Alliance release ``Improve Consumer
    Health & Safety: Increase FDA Funding'' at http//www.strengthenfda.org/
    FDA_Alliance_Booklet_Complete.pdf.
        21. FDA Science Board supra at 56.
        22. FDA Science Board, supra at 53.
        23. Outbreak Alert Database, supra. See also, Sonja J. Olsen et
    al., Surveillance for Foodborne Disease Outbreaks--United States, 1993-
    1997, MMWR Surveillance Summaries available at http://www.cdc.gov/mmwr/
    preview/mmwrhtml/ss4901
    al.htm for additional tables on the number of foodborne disease
    outbreaks by year and place where food was eaten.
        24. FDA, Food Protection Plan, Nov. 2007, 6.
        25. USDA, FY 2008 Budget Summary and Background, 59, at http://
    www.obpa.usda.gov/budsum/fy08budsum.pdf.
        26. Outbreak Alert Database, supra.
          Response to Questions of Senators Kennedy, Enzi, and Allard
                              by Paul Young, Ph.D.
                          questions of senator kennedy
        Question 1. You raised concerns about relying on voluntary efforts
    by the industry. Could you please expound on the problems with a
    voluntary approach to food safety?
        Answer 1. Unsurprisingly, it is more expensive to produce food
    which is free of contaminants than otherwise. Pesticides and veterinary
    drugs are often used in crop and animal production, respectively,
    specifically to increase production gains. For example, it is well-
    documented that prophylactic use of antibiotics in animal production
    will not only prevent disease from occurring in the animals, but will
    also act as a growth promoter significantly improving feed conversion
    (i.e., more growth for the same amount of animal feed consumed). There
    is therefore a significant financial incentive for producers to use
    these chemicals to reduce costs and increasing profit margins.
        FDA currently operates a voluntary approval scheme listing foreign
    producer establishments that importers are recommended to use when
    sourcing seafood for import into the United States. Due to the
    voluntary nature of this scheme, only four countries have submitted
    lists of establishments (Canada, Japan, New Zealand and Thailand),
    whereas 95 have done so to the European Union where approval is
    mandatory. Additionally, FDA recommends that ``Importers may consider
    purchasing from processors that are on such lists, and documenting that
    they are doing so, as one way of meeting their affirmative steps
    responsibility . Despite this recommendation for voluntary action, many
    of the seafood import consignments refused entry by FDA during October
    2007 originated from processing establishments not cited on the
    approved lists (even where those lists exist).
        Clearly, the current voluntary approach carries little weight and
    given the price competitive nature of food production, a voluntary
    system does little to remove the incentive to use agricultural
    chemicals inappropriately.
        It should also be noted that unlike pathogen contamination where
    acute disease conditions in consumers can act as indicators or
    ``signals'' of contamination, many of these agricultural chemicals,
    whilst being both genotoxic and carcinogenic may not give rise to acute
    conditions and left undetected could result in long-term effects.

        Question 2. Mr. Taylor talked about food safety from farm-to-table.
    Ms. Smith DeWaal talked about food safety on farms, and Mr. Dooley
    mentioned good agricultural practices for produce. Traditionally, the
    FDA doesn't play a huge role on farms or at retail establishments. Do
    you have some suggestions about how we could enhance FDA's role there
    without raising the obvious sensitivities? What role can the States
    play? Do the authorities in the European Union and Japan have
    regulatory authority on farms and at retail?
        Answer 2. As part of its farm-to-table approach, the European Union
    introduced legislation in 2004 (Regulation (EC) No. 852/2004) which
    requires all food business operators to implement and maintain a Hazard
    Analysis and Critical Control Point programme (HACCP). Whilst it is
    accepted that HACCP implementation is not yet feasible for primary
    production (although this is scheduled for review), it recommends that
    primary producers should implement these procedures as far as possible
    and additionally details specific hygiene measures and recordkeeping
    required by producers involved in both animal rearing and plant
    production. All of this inevitably increases the record-keeping burden
    of farmers and in Europe many farmers are increasingly turning to
    dedicated IT solutions, some of which can be managed from the field. I
    understand that Japanese authorities also strictly control the
    distribution of pesticides and veterinary drugs and enforce regulations
    mandating farmers to keep records regarding their use and withdrawal.

        Question 3. You testified that Japan tests 10 percent of its
    imported food. Do you believe it is practical for the United States to
    test 10 percent of its imported food, and if not, is there a practical
    alternative?
        Answer 3. Testing per se does not make the food safe, but serves to
    demonstrate compliance with required standards of production, thereby
    building consumer confidence. With regard to the practicality of 10
    percent testing in the United States, FAO figures for the top 20
    agricultural import commodities indicate that Japan imports
    significantly more than the United States, by volume. This would
    indicate that a 10 percent level of testing is achievable.
        However, the figure of 10 percent cited in my testimony relates to
    the level of food imports undergoing laboratory analysis in Japan. The
    equivalent figure for the United States is currently quoted at around
    0.2 percent. A shift to 10 percent testing would represent a 50-fold
    increase in the current level of laboratory analysis in the United
    States. Whilst employing the latest technological advances, such as the
    recent innovations from Waters, will help both in terms of cost
    effectiveness and throughput, clearly this would still require
    additional resources. Europe, for example, makes provision to allow
    testing to keep pace with import levels by funding imported food
    testing from a levy imposed on the importers, legislating to allow
    governments to recover up to the full cost of sampling and analysis.
                           questions of senator enzi
        Question 1. You mention in your testimony a seafood export action
    plan whereby shipments in violation of the EU regulations could be sold
    into less stringent markets. Since a number of countries are
    overhauling their food safety systems, how do we get it right here at
    home while maintaining harmonization with other countries?
        Answer 1. Situations like this arise because effective global
    harmonization of standards does not yet exist and because when import
    requirements are not either clearly stated or robustly enforced, they
    may be interpreted as being optional. When developing standards for
    U.S. domestic production, one must also bear in mind that the United
    States is the world's largest exporter of agricultural commodities and
    as you suggest, it is highly desirable to have standards acknowledged
    as offering equivalence with the requirements of export markets as
    described within the WTO SPS agreement. Implementing standards in line
    with the recommendations of Codex Alimentarius Commission will help,
    where these Codex standards exist. Otherwise, equivalence can only be
    assured through a comprehensive understanding of food safety
    requirements of each country or market. It is for precisely this reason
    that we in Waters Corporation are actively involved in discussions
    regarding food safety legislation with regulators in many countries, in
    order to facilitate this exchange of information.

        Question 2. The EU and Japan have a food risk analysis body
    separate from the risk management side. I worry that these two sides
    would be too isolated from each other--I think risk assessment and risk
    management are iterative. You need those two functions to work together
    and learn from one another. Can you comment on how effective or not
    effective this separation is?
        Answer 2. I can see both sides of this argument. I completely agree
    that close cooperation between risk assessment and management is
    absolutely essential, particularly with regard to ensuring effective
    and timely intervention. Indeed, exchange of scientific information is
    also key to ensuring that control measures are both necessary and
    appropriate. On the other hand, one vital role of food safety
    regulation involves maintaining consumer confidence. There is a risk,
    if both functions are covered by one organization that, either in
    reality or in the public's perception, the practicalities of risk
    management may influence the risk assessment and subsequent control
    measures. This separation ensures that regulations are based on science
    and the scale of control measures are appropriate to effectively manage
    the risk and are not dictated by the availability of resources. From my
    experience working in risk management in the UK, this system of
    separation works well, but only because of the very close collaboration
    and interaction that exists between both sides.

        Question 3. We heard a lot about Radio-Frequency Identification
    (RFID) at last year's hearing, but it seemed that the conclusion was
    that this isn't ready for prime time, at least at the unit-of-sale
    package level. How is the EU implementing the requirement for full
    traceability?
        Answer 3. Certainly, RFID is receiving a lot of attention for the
    traceability advantages it offers. However, food production is a very
    price conscious environment and reports indicate that early adopters of
    RFID appear to be struggling to justify the relatively high cost
    associated with this technology, which would agree with your assessment
    that it may not yet be appropriate for food traceability. There is a
    requirement for traceability in EU food law which it defines as ``the
    ability to trace and follow a food, feed, food-producing animal or
    substance intended to be, or expected to be incorporated into a food or
    feed, through all stages of production, processing and distribution.''
    The EU has published guidelines which require food business operators
    to document the names and addresses of the supplier and customer in
    each case, as well as the nature of the product and date of delivery.
    In addition to the general requirements, sector-specific legislation
    applies to certain categories of food products (fruit and vegetables,
    beef, fish, honey, olive oil) so that consumers can identify their
    origin and authenticity. In the case of animals, producers must now
    ``tag'' every one with details of their origin and, when animals are
    taken for slaughter, stamp them with the traceability code of the
    abattoir. The tools used (ear tags, passports, bar codes) may vary from
    one country to another but must carry the same information.

        Question 4. Whenever people talk about international standards, ISO
    comes up for discussion. I think they do a lot of great things, but
    when it comes to food safety, is ISO good enough?
        Answer 4. There is no doubt that ISO standards play an important
    role in food safety. For example, the accreditation standard ISO 17025
    is widely accepted as being highly desirable for laboratories involved
    in food safety analysis. However, ISO standards regarding safe food
    production are still evolving (such as the recent standards ISO
    22000:2005 on hazard control and ISO 22005:2007 on traceability) and
    have yet to find widespread application. Many producers therefore
    choose to implement the Hazard Analysis and Critical Control Point
    (HACCP) recommendations to demonstrate due diligence. In Europe there
    is a legislative requirement for all food business operators to
    implement a HACCP programme. Indeed, some of the evolving ISO standards
    seek to standardize the implementation of HACCP.
                          questions of senator allard
        Question 1. In your opinion what can be done to further educate the
    public, private sector and interested government agencies on food
    safety, recalls, etc.''
        Answer 1. This would appear to require considerable collaboration
    involving all interested parties. In a European survey, when asked who
    consumers most trust to inform them of a serious food risk, public
    authorities came fourth (behind consumer groups, physicians and
    scientists). Key elements appear to lie in maintaining the trust of the
    consumers and in providing them with accurate, easily understood
    information. In food recalls that I have been involved with in the
    past, the relevant agencies issued photographs of affected product,
    making it easy for consumers to establish whether they need to take
    action or not. I understand that this is currently being piloted by FDA
    and the consumer feedback should be most interesting.
        Effective training for scientists involved in food safety analysis
    is also vital in ensuring that methods of analysis are appropriate and
    offer satisfactory assurances of product compliance. This necessity
    extends beyond U.S. borders, since imported food safety inevitably
    relies, to a large extent, on assurances provided by laboratories in
    those exporting countries. Waters Corporation has had discussions with
    a number of U.S. executive agencies who are regularly approached by
    scientists from foreign laboratories requesting training. It has been
    suggested that the establishment of a food safety institute capable of
    offering specialized scientific training to both domestic and foreign
    scientists would be of great benefit.

        Question 2. Do you think that further education should play a role
    in addressing food safety? Do you have a single suggestion to further
    education and the distribution of informative resources regarding food
    safety?
        Answer 2. In addition to the frequently discussed risk assessment
    and risk management strategies, risk communication also plays an
    extremely important role in food safety control. If consumers are
    presented only with the bald facts of potential hazards associated with
    a particular foodstuff, without the balanced view of the potential
    health benefits to be gained from wholesome product, it is likely to
    initiate complete avoidance which will, not only, damage the business
    of the vast majority of responsible producers but may also limit the
    source of valuable nutrients for the consumers. In a recent European
    survey 53 percent of people surveyed claimed to have changed their
    eating habits as a result of hearing about a food hazard, with 16
    percent stating that this change was permanent. The challenge then lies
    in building confidence for consumers that they are being both
    adequately protected and informed. If pressed to make a single
    suggestion regarding dissemination of information, it would be to
    create a single central repository for information relating to all
    aspects of food safety, ensuring that the message is consistent,
    comprehensive and, above all, easily understood by consumers.

        [Whereupon, at 12:38 p.m. the hearing was adjourned.]